ENISA Report - Cloud Security For Healthcare Services

1
CLOUD SECURITY
FOR HEALTHCARE
SERVICES
JANUARY 2021
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CLOUD SECURITY FOR HEALTHCARE SERVICES
January 2021
ABOUT ENISA
The European Union Agency for Cybersecurity, ENISA, is the Union’s agency dedicated to
achieving a high common level of cybersecurity across Europe. Established in 2004 and
strengthened by the EU Cybersecurity Act, the European Union Agency for Cybersecurity
contributes to EU cyber policy, enhances the trustworthiness of ICT products, services and
processes with cybersecurity certification schemes, cooperates with Member States and EU
bodies, and helps Europe prepare for the cyber challenges of tomorrow. Through knowledge
sharing, capacity building and awareness raising, the Agency works together with its key
stakeholders to strengthen trust in the connected economy, to boost resilience of the Union’s
infrastructure, and, ultimately, to keep Europe’s society and citizens digitally secure. For more
information, visit www.enisa.europa.eu.
CONTACT
For contacting the authors please use eHealthSecurity@enisa.europa.eu
For media enquiries about this paper, please use press@enisa.europa.eu.
AUTHORS
Dimitra Liveri, Dr. Athanasios Drougkas, Antigone Zisi, EU Agency for Cybersecurity
ACKNOWLEDGEMENTS
For providing valuable information that helped shape the report (in alphabetical order):
Belani Hrvoje, Croatia Ministry of Health, Croatia
Bezouška Tomáš, Ministry of Health of the Czech Republic, Czech Republic
Calcavecchia Franck, Hôpitaux Universitaires Genève, Switzerland
Callewaert Frank, Microsoft, Belgium
Carbonell Marta, Hospital Universitary Vall d'Hebron, Spain
Chondropoulos Konstantinos, General Hospital of Thessaloniki "George Papanikolaou", Greece
Drost René, NAMCO, Netherlands
Gioulekas Fotios, University Hospital of Larissa & 5th Regional Health Authority of Thessaly and
Sterea, Greece
Greenfield Søren Bank, Danish Health Data Authority, Denmark
Haro Albert, Cybersecurity Agency of Catalonia, Spain
Ikäheimonen Merja, Essote ky, Finland
Kirkmann Perit, Information System Authority, Estonia
Kokx Ben, Philips, Netherlands
Liebscher Thomas, Philips, Netherlands
Marek Dominik, Vysočina Region Regional Authority, Czech Republic
Meany Ben, Microsoft, Belgium
Pennings Florian, Microsoft, Belgium
Rad Abtin, TUEV SUED Product Service GmbH, Germany
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Smethurst Chelsea, Microsoft, Belgium
Starolis Saulius, National Health Insurance Fund under the Ministry of Health, Lithuania
Tzikas Athanasios, University Hospital of Larissa, Greece
Žukovskis Raivis, The National Health Service of the Republic of Latvia, Latvia
LEGAL NOTICE
Notice must be taken that this publication represents the views and interpretations of ENISA,
unless stated otherwise. This publication should not be construed to be a legal action of ENISA
or the ENISA bodies unless adopted pursuant to the Regulation (EU) No 2019/881.
This publication does not necessarily represent state-of the-art and ENISA may update it from
time to time.
Third-party sources are quoted as appropriate. ENISA is not responsible for the content of the
external sources including external websites referenced in this publication.
This publication is intended for information purposes only. It must be accessible free of charge.
Neither ENISA nor any person acting on its behalf is responsible for the use that might be made
of the information contained in this publication.
COPYRIGHT NOTICE
© European Union Agency for Cybersecurity (ENISA), 2021
Reproduction is authorised provided the source is acknowledged.
Copyright for the image on the cover: © Shutterstock

For any use or reproduction of photos or other material that is not under the ENISA copyright,
permission must be sought directly from the copyright holders.
ISBN 978-92-9204-405-3, DOI 10.2824/454966
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January 2021
LIST OF ABBREVIATIONS
Abbreviations Definitions
ANSSI Agence Nationale de la Sécurité des Systèmes d'Information
API Application Programming Interface
AWS Amazon Web Services
BSI British Standards Institution
CCN Centro Criptológico Nacional
CDS Clinical Decision Support
CIO Chief Information Officer
CISO Chief Information Security Officer
CMMC Cybersecurity Maturity Model Certification
COVID Corona Virus Disease
CSA Cloud Security Alliance
CSP Cloud Security Provider
DP Data Protection
DSI Digital Service Infrastructure
EC European Commission
EDPB European Data Protection Board
EDPS European Data Protection Supervisor
EFTA European Free Trade Association
EHR Electronic Health Record
ERP Enterprise Resource Planning systems
EU European Union
GDPR General Data Protection Regulation
GP Good Practice
HCO Health Care Organisation
HDS Hébergeurs de Données de Santé
HDSI Health Digital Service Infrastructure
HIPPA Health Insurance Portability and Accountability Act
HIS Health Information Systems
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HITRUST Health Information Trust Alliance
IACS Industrial Automation and Control Systems
ICT Information and Communications Technology
IEC International Electrotechnical Commission
IMDRF International Medical Device Forum
JASEHN Joint Action to Support the eHealth Network
LIS Laboratory Information System
MS Member States
NISD Network and Information Security Directive
NIST National Institute of Standards and Technology
OS Operating System
OWASP Open Web Application Security Project
PACS Picture Archiving and Communication System
PHP Hypertext Pre-processor (scripting language)
RIS Radiology Information System
RPM Remote Patient Monitoring
SLA Service-Level Agreement
SM Security Measure
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TABLE OF CONTENTS
1. INTRODUCTION 8
1.1 CONTEXT OF THE REPORT 8
1.2 OBJECTIVE 8
1.3 SCOPE 8
1.4 TARGET AUDIENCE 9
1.5 METHODOLOGY 9
1.6 STRUCTURE OF THE DOCUMENT 9
2. HEALTHCARE IN THE CLOUD 10
2.1 POLICY CONTEXT 10
2.1.1 The Network and Information Security Directive (NISD) 11

2.1.2 General Data Protection Regulation 11
2.1.3 Non regulatory guidelines 11
2.2 CLOUD COMPUTING BASICS 12
2.2.1 Cloud Services 12

2.2.2 Cloud Deployment models 13
2.2.3 Division of responsibilities 13
2.3 TYPES OF CLOUD SERVICES IN HEALTHCARE 14
3. CYBERSECURITY CONSIDERATIONS IN CLOUD FOR

HEALTHCARE 16
3.1 CLOUD SECURITY CHALLENGES FOR HEALTHCARE 16
3.2 DATA PROTECTION CHALLENGES IN THE CLOUD 17
3.3 CYBERSECURITY THREATS 18
4. USE CASES 21
4.1 USE CASE 1 - ELECTRONIC HEALTH RECORD 21
4.2 USE CASE 2 – REMOTE CARE 23
4.3 USE CASE 3 – MEDICAL DEVICES 26
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5. CLOUD SECURITY MEASURES 29
5.1 CLOUD SECURITY MEASURES AND GOOD PRACTICES 29
6. CONCLUSION 39
7. REFERENCES 40
A ANNEX: GENERAL PRACTICES 42
B ANNEX: MAPPING OF SECURITY MEASURES 44
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EXECUTIVE SUMMARY
The healthcare sector is going through the digitalisation process and continuously adopting new
technology to improve patient care, offer new services focusing on patient-at-home care, and
reach operational excellence. The integration of new technology in an already complex IT
infrastructure opens up new challenges regarding data protection and cybersecurity. Moreover,
the ongoing COVID-19 pandemic has been a further catalyst for cyberattacks on healthcare
organisations1,2,3. Typical examples are phishing attacks that aim to collect user credentials of
healthcare professionals and ransomware4 against hospitals and other Healthcare
Organisations (HCO).
At the same time this pandemic stresses the need for remote healthcare services, since the
system was overwhelmed in some countries and physical presence was a risk for the spread of
the pandemic. In this context, Cloud solutions have provided elasticity and fast access for the
deployment of new services including «virtual» health and telemedicine.
This study aims to provide Cloud security practices for the healthcare sector and identify
security aspects, including relevant data protection aspects, to be taken into account
when procuring Cloud services for the healthcare industry.
The set of general practices aims to help IT professionals in the healthcare security contexts to
establish and maintain Cloud security while selecting and deploying appropriate technical and
organisational measures. The identification of relevant threats and risks to Cloud services in the
healthcare industry and security and data protection requirements are also covered by the
scope of this report. Further objectives include the presentation of informative and practice-
oriented use cases and their analysis of relevant threats and Cloud security measures.
The overall conclusion derived from the study, is that Cloud integration in the healthcare sector
in the EU is still in its infancy. Some healthcare organisations hesitate to adopt Cloud services,
because they are challenged by a dense and complex legal basis, and new technologies.
Furthermore, the loss of data governance and processing of personal data in the Cloud makes
healthcare organisations hesitant to adopt Cloud services. Other healthcare organisations use
PaaS for connecting medical devices with a web-application for remote monitoring of patients or
SaaS for documentation and scheduling doctor-patient consultations. Some countries are in the
beginning of forming a Government Cloud (G-Cloud) to satisfy such needs. There are also
various government managed services such as electronic prescription and electronic health
records, which run on government-owned resources, such as private Clouds and state owned
datacentres and Clouds.
The study is structured around three use cases, which are the most prominent in using Cloud or
to be using in the future, namely Electronic Health Record, Remote Care and Medical Devices.
A set of 17 security and data protection measures has been identified to be relevant for
ensuring Cloud security and have been assessed based on the use case.
1
https://www.verdict.co.uk/healthcare/
2
https://healthitsecurity.com/news/covid-19-impact-on-ransomware-threats-healthcare-cybersecurity
3
https://healthitsecurity.com/news/the-10-biggest-healthcare-data-breaches-of-2020-so-far
4
https://us-cert.cisa.gov/ncas/alerts/aa20-302a
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1. INTRODUCTION
1.1 CONTEXT OF THE REPORT

The healthcare sector is one of the sectors most vulnerable to cyber attacks5. Simultaneously, COVID-19
the digitalisation of the healthcare sector is moving forward, and digital solutions or electronic
pandemic
records continuously replace paper-based processes. The transformation affects services along
the complete healthcare delivery chain, i.e. medication, appointment scheduling, patient
indicated how
records, inpatient and outpatient care as well as inpatient and remote monitoring or self- vulnerable the
management. healthcare
sector is to
Digitalisation offers new solutions to improve patient care and gain operational excellence in
cyberattacks
healthcare organisations. Cloud solutions for healthcare services offer an excellent opportunity
to increase operational efficiency, cut costs on IT expenditure and improve cybersecurity and
and the need for
data protection. This is since Cloud service providers have resources such as personnel, “tele” medicine
knowledge of technology, and the financial means to improve cybersecurity and data protection also as a more
continuously. These are the same factors that sometimes have proven to hinder advances in secure solution.
the maturity of data protection and cybersecurity at healthcare organisations.
The COVID-19 pandemic has pushed Cloud-based technology usage in the healthcare sector,
especially in telemedicine, for patient-doctor consultations and artificial intelligence for triaging
purposes. The further integration of Cloud computing services in the healthcare sector also
raises security and data protection concerns. This report therefore aims to help ensure Cloud
security for healthcare.
1.2 OBJECTIVE
This report's overall objective is to provide the target audience with a set of guidelines to ensure
cybersecurity and security of personal data processing when procuring Cloud services for
providing healthcare services and a clear understanding of the corresponding responsibilities.
The goals are to provide an overview of the landscape of the applicable EU legislative
instruments relevant to Cloud services in the healthcare sector and the main cybersecurity and
data protection challenges, relevant to security of personal data processing, of Cloud customers
from the healthcare sector.
1.3 SCOPE
The study's scope is Cloud services that support the broader eHealth ecosystem, such as
healthcare services and facilities, medical devices and equipment, medical services, or
managed care. It is not limited to a specific Cloud architecture, neither deployment nor service
model. The study focuses on showing relevant threats, measures, and responsibility by
analysing three representative use cases, electronic health record, remote care, and medical
devices.
The set of guidelines for Cloud security of healthcare services (output) is primarily for Cloud
customers, such as healthcare organisations or medical device manufacturers. The study,
investigation, and the output are centred on the European Union and European Free Trade
Association (EFTA) member states.
5
IBM, X-Force Threat Intelligence Index, 2020, pp. 39., see also Moore, J., Which sectors are most vulnerable to cyber
attacks, 2020. https://www.ifsecglobal.com/cyber-security/which-sectors-are-most-vulnerable-to-cyber attacks/
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1.4 TARGET AUDIENCE

The target audience of the study’s output acceptable practices for ensuring Cloud security for
healthcare services is anyone interested in using Cloud technology in the healthcare sector.
The main focus is on Cloud customers in healthcare, primarily:
 IT health professionals (CISO, CIO, IT procurement specialists, and IT-teams in charge

of purchasing Cloud services)
 Healthcare professionals in managerial positions seeking advice on whether to procure
Cloud services
The report may be useful to IT professionals from medical device manufacturers and possibly,
policymakers and Cloud service providers.
1.5 METHODOLOGY
The applied methodology of this study comprises four steps.
 Step 1 Desk Research: Extensive desk research for gathering information identifying
Cloud services supporting healthcare services, Cloud security threats, and security
controls for providing Cloud security for healthcare in general and during the
procuring process.
 Step 2 Questionnaire and semi-structured interviews: Experts and
representatives from the healthcare and Cloud technology industry of ENISA’s expert
network have provided information on Cloud-based healthcare services, its
associated risks and opportunities, Cloud security and cybersecurity requirements in
general, and implemented or identified cybersecurity and data protection measures
from their point of view. Interviews have been conducted to collect additional valuable
input from the experts.
 Step 3 Analysis: The analysis of the results from step 1 and step 2 provides input for
the report and its objectives. This step supports the identification of security
challenges and the validation of the use cases. Based on the analysis results, the first
draft of the report has been drafted.
 Step 4 Review and validation: The last step comprises the review and validation by
ENISA’s expert group. The final version of the report is drafted, taking into account
the feedback from the experts.
1.6 STRUCTURE OF THE DOCUMENT

The report is structured as follows:
 Section 1 – Introduction provides introductory information on the report and

describes the scope, objectives, target audience, and the applied methodology.
 Section 2 – Cloud Services in Healthcare outlines Cloud service terminology,
characteristics, and responsibilities. It includes an overview of Cloud services in
healthcare identified through desk research and interviews.
 Section 3 – Cybersecurity considerations in Cloud for Healthcare entails
cybersecurity and data protection considerations for the use of Cloud for healthcare
services. It also includes a threat taxonomy based on the ENISA procurement guide.
 Section 4 – Use cases shows a description of the possible use cases, the factors to
be considered when conducting the respective risk analyses in terms of risk likelihood
and impact, and appropriate security measures, relevant to personal data processing,
for risk mitigation.
 Section 5 – Cloud security measures in healthcare lists and presents measures
for ensuring Cloud security for healthcare services, including additional data
protection considerations.
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2. HEALTHCARE IN THE
CLOUD
2.1 POLICY CONTEXT

Legislation plays an important role in defining cybersecurity requirements and adopting
cybersecurity and data protection related measures. In the case of healthcare and the Cloud,
the policy landscape at national or European level is still at early stages of development. Very
few MS have Cloud-related guidelines specifically for the healthcare sector, simply because if
Cloud security guidance is in place, it applies to all critical sectors; all Member States consider
healthcare a critical sector.
The general conclusion derived from the desk research and expert interviews shows that MS
have a dedicated legislation for healthcare activities (not necessarily covering cybersecurity)
and in several cases they adopt cybersecurity guidelines for Cloud computing; there is no case
of healthcare and Cloud specific legislation. This corresponds to the assessment of the
healthcare sector as critical, thus required to abide by overall cybersecurity legislations and
guidelines.
At the same time, identification of requirements deriving from national or European legislation,
proves crucial when procuring Cloud services. Some healthcare services, electronic health
records for instance, have a separate law entailing security and data protection requirements.
And eventually, to some extent the general practices overlap.
The illustration below depicts the legislative situation regarding Cloud security and healthcare.
From a legal requirements perspective, we examined four topic-related dimensions: privacy,
cybersecurity, Cloud security, and healthcare.
Figure 1: Legislations related to Cloud security and healthcare
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The most relevant legal documents or guidelines at EU level are summarised below.
2.1.1 The Network and Information Security Directive (NISD)

The Network and Information Security Directive (NISD) 2016/1148/EU6, which came into force in
May 2018, has two main goals: the implementation of minimum security requirements and the
establishment of cybersecurity notifications for both Operators of Essential Services and Digital
Service Providers. Healthcare providers, namely hospitals, are identified as Operators of
Essential Services in most Member States. At the same time Cloud Service Providers are
considered Digital Service Providers. Therefore, both these types of organisations will have to
take the Directive and the relevant national law into account when contracting a Cloud service.
The Directive goes beyond implementation of security requirements, as it gives power to the
regulatory bodies to audit the Operators of Essential Services to ensure the level of
cybersecurity in the organisation is acceptable and as per the provisions of the Directive. At the
same time, the Directive puts in scope specific services which span among the designated
essential sectors. In the healthcare ecosystem, this can be translated as cybersecurity
requirements for all products so it should be included as a provision in the procurement
process.
For the Digital Service Providers, the decision on the details of cybersecurity measures resides
with the MS, since the Directive leaves a certain level of flexibility. In the case of Cloud services
offered to an operator of essential healthcare service, both parties need to agree on how the
legal requirements will be met before reaching a contractual agreement.
2.1.2 General Data Protection Regulation

The General Data Protection Regulation (GDPR)7 came into force on 25 May 2018. It sets the
rules for the processing and free movement of personal data and applies to all domains of the
public and private sector; however, some specific derogations are defined for data concerning
health, aimed at protecting the rights of data subjects and confidentiality of their personal health
data and at the same time preserving the benefits of data processing for research and public
health purposes.
The GDPR considers health data as a "special category" of personal data which are considered
to be sensitive by nature and imposes a higher standard of protection for their processing.
Organisations (Data controllers) processing health data have the following obligations (among
others):
 to implement appropriate technical and organisational measures to ensure security of

the processing systems, services and personal data,
 to perform data protection impact assessment, and
 to report data breaches which are likely to result in a risk to the rights and freedoms of
individuals within 72 hours after having become aware of them.
The GDPR expanded the scope of application of EU data protection law requirements to the
data processors as well. This means that Cloud service providers, acting as data processors on
behalf of the data controller, have obligations as data controllers but their obligations would not
necessarily be the same.
2.1.3 Non regulatory guidelines

Prior to the adoption of GDPR, in 2012, the European Data Protection Supervisor (EDPS) had
issued an opinion on the use of Cloud Computing and provided guidance indicating security
measures for data protection but also sharing considerations in respect to responsibilities
6
https://eur-lex.europa.eu/eli/dir/2016/1148/oj
7
https://eur-lex.europa.eu/eli/reg/2016/679/oj
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January 2021
between data processor and data controller. This can be used as a basis for Cloud security
requirements solicitation from the healthcare sectors as well.
In 2015, the Joint Action to Support the eHealth Network (JASEHN) issued a report8 on the use
of Cloud computing in health focusing primarily on the secondary use of health data where
amongst other explains the responsibility shift between the HCO and the CSP based on the
service model (IaaS, PaaS, SaaS etc).
In 2018, the European Data Protection Board (EDPB) and the EDPS issued an opinion9
specifically for healthcare namely on data protection for eHealth Digital Service Infrastructure
compiled under the directive on patients’ rights to cross-border healthcare. Amongst other
things, the opinion includes requirements for more secure information exchange (i.e.
encryption), secure data storage and that the EC, as data processor, has to clarify the
governing rules of the processing.
2.2 CLOUD COMPUTING BASICS
2.2.1 Cloud Services

As per previous ENISA publications10, the basic types of Cloud services can be explained in the
following diagram:
Figure 2: Basic types of Cloud services
Interpreting the diagram from left to right:
 Infrastructure as a Service: In IaaS, the provider delivers computing resources (virtual

hardware), accessible online. The software providing access to the resources is called
the hypervisor. Generally speaking there are two types of resources: processing power
8
https://webgate.ec.europa.eu/chafea_pdb/health/projects/677102/outputs
9
https://edps.europa.eu/data-protection/our-work/publications/opinions/edpb-edps-joint-opinion-ehdsi_en
10
https://www.enisa.europa.eu/topics/cloud-and-big-data
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(including network resources), and (block) storage (memory resources). Examples

include Amazon’s Elastic Compute Cloud, Google’s Compute Engine, Amazon Simple
Storage Service, Dropbox, Rackspace, etc. Note that object storage services (e.g.
Dropbox) are often considered SaaS.
 Platform as a Service: In PaaS, the provider delivers a platform, or more precisely,

application servers, for customers to run applications on. PaaS providers sometimes
provide a software development tool for the platform. Examples of applications running
on these platforms are scripts (PHP, Python, e.g.) or byte code (Java servlets, C#).
Examples include Google App engine, Microsoft Azure, Amazon Elastic Beanstalk, etc.
 Software as a Service: In SaaS, the provider delivers full-fledged software or

applications, via the internet. Applications range from email servers, document editors,
customer relationship management systems, and so on. SaaS services can often be
accessed with a browser or a web services client. Note that it is not uncommon for
SaaS providers to run their applications on an IaaS or PaaS from another provider. An
example is the video streaming site Netflix (SaaS) which runs on Amazon AWS
computing services (PaaS/IaaS).
 Facilities denote the physical structures and supplies such as networks, cooling,
power, etc.
 Organisation denotes the human resources, the policies and procedures for
maintaining the facilities and supporting the delivery of the services.
2.2.2 Cloud Deployment models

Private Cloud is a model in which one customer has exclusive access to the Cloud
infrastructure and computational resources, that can be hosted by the customer itself or a
provider, over a private network.
Public Cloud refers to a shared Cloud infrastructure and computational resources that are
available and reachable over the public internet.
Hybrid Cloud is a model for a group of users that share the same Cloud infrastructure and the
computational resource. The premises may be owned, managed, and operated by one or more
of the organisations in the community, a third party, or both. It may exist on the community’s
location (on-site) or the third-party’s location (off-site).
Governmental Cloud (g-Cloud) is a Cloud environment where the Cloud infrastructure is

owned, governed and run by the government or a state-owned entity using own resources or a
selected third-party provider. In addition, the governmental Cloud enables the public body to
provide services to public sector stakeholders, to citizens and enterprises.
For the purpose of this report, the definition of governmental Cloud is presented based on
ENISA’s reports11.
2.2.3 Division of responsibilities

Similarly depending on the service model selected, the responsibilities might lie either on the
side of the customer or of the provider; the higher you move in the service stack as a customer
the fewer technical responsibilities one has to implement. Note that this diagram is for
illustration only and does not provide an exhaustive list of security processes on the provider’s
or the customer’s side. In specific settings there may be specific agreements about the
11
https://www.enisa.europa.eu/topics/cloud-and-big-data/cloud-security
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outsourcing of security tasks. An IaaS provider, for example, might have a service for patching
the Operating System (OS) of customers. Sometimes such services are offered by a third-party
(and this is also known as Security-As-A-Service or SECaaS).
At this point, it needs to be stressed that cybersecurity is always a shared responsibility- so

regardless of the service model acquired, the customer always has a role in the cybersecurity or
privacy requirements adoption.
Figure 3: Division of responsibilities of Cloud services
From the data protection perspective, the definitions and most likely assignment of roles are as
follows:
 Data controller: “the natural or legal person, public authority, agency or other body
which, alone or jointly with others, determines the purposes and means of the
processing of personal data” GDPR Art. 4(7).
 Data processor: “a natural or legal person, public authority, agency or other body
which processes personal data on behalf of the controller” GDPR Art. 4 (7).
Depending on the service model (IaaS/PaaS/SaaS), the data processor might be the
CSP or the customer. The higher a healthcare organisation moves up the Cloud
services stack, the more processing power the Cloud provider has.
2.3 TYPES OF CLOUD SERVICES IN HEALTHCARE

In the healthcare sector, Cloud solutions exist for different healthcare services and their number
is increasing. In this chapter, we provide a non-exhaustive overview of the currently identified
Cloud solutions for healthcare systems. These solutions may come in different cloud service
types (e.g. SaaS, PaaS etc.) or cloud deployment models. The following descriptions focus
primarily on the types of functions and services supported by existing cloud services as
opposed to the deployment models and relevant architectures.
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Table 1: Non-exhaustive overview of the currently identified Cloud solutions for healthcare systems
Type of cloud services Description
Enterprise resources planning systems support the management of patients, appointments, medical
staff’s schedules and inventory. Dedicated parts of an ERP system could be available as Cloud-
based solutions, for instance:
Enterprise resource  Patient management system
planning systems
(ERP systems)  Health insurance management
 Billing and human resource management
 Other non-clinical data management
Health information systems are used for managing healthcare data and entail demographic and
medical patient data, which comprise records, images, or even videos. In the area of health
information systems, the following types are available or used as a Cloud-based solution:
 Electronic health record (EHR)
 Picture archiving and communication system (PACS)
Health information
systems (HIS)  Electronic prescription information system
 Radiology information system (RIS)
 Laboratory information system (LIS)
 Clinical decision support (CDS)
 Remote patient monitoring (RPM)
Middleware is a communication service to transfer data between systems or devices with a different
Communication physical location. For instance, in a Cloud-based solution for a remote monitoring solution, only the
services transfer from the device to the electronic health record is Cloud-based with the medical data being
stored at a data storage facility in the healthcare organisation.
Healthcare organisations use Cloud-based file servers for document archiving or mail servers for
Office management
internal and external communication.
Cloud-based networks enable healthcare organisations to share infrastructure on an as-needed

Cloud-based network
basis; therefore, having more flexibility if more resources in particular situations are required.
Health data analytics need a lot of computing power. Healthcare organisations outsource this task
with Cloud technologies.
Health data analytics Artificial intelligence12, machine learning is used to support medical research, diagnosis (e.g. cancer13
or cardiac pathology14), data analysis (e.g. glucose measurement), treatment recommendation, and
patient engagement. The use of Cloud computing technology for this area is continuously evaluated.
Medical devices identify data that can be accessed through a mobile app or a web-based platform
from different stakeholders. The healthcare services provided using Cloud-based medical devices are
blood pressure measurement using electronic stethoscope15, glucose measurement, and
Medical devices electrocardiogram. The goal is to enable patients to measure heart rates or insulin level at home while
the data is directly available to healthcare professionals for treating or scheduling an appointment.
Diagnostic cameras that support healthcare professionals during the diagnosis also belong to this
category.
Telemedicine is a healthcare service provided using telecommunication technology. The areas of

Telemedicine services application comprise of teleconsultation and tele assistance using conference or video-conference
tools.
Medication assistance16 supports patients following their medication through real-time monitoring. It is
Medication monitoring
a further remote healthcare technology application17 together with telemedicine and medical devices.
Supply chain Supply Chain Management guarantees the timely availability of safe medical devices for use in the
management healthcare processes. This includes equipment, implants, disposables and medical software.
12
Davenport and Kalakota, 2019
13
Junaid Ahmad, Vinai, Bilal, 2015 and Sadhasivam, Balamurugan, and Pandi, 2018
14
Agliari et al., 2020
15
Leng et al. 2015
16
Ventsislav and Rosen, 2016
17
Cavoukian et al., 2010
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3. CYBERSECURITY
CONSIDERATIONS IN CLOUD
FOR HEALTHCARE
3.1 CLOUD SECURITY CHALLENGES FOR HEALTHCARE

In this section, we present the main challenges regarding Cloud security, derived from the input
of different experts collected through interviews. Even if the list is not exhaustive, the identified
challenges comprise trends and obstacles regarding cybersecurity and data protection of the
healthcare sector and the risks from Cloud-based healthcare services.
 Lack of trust of Cloud solutions: Overall, it has become evident that stakeholders in
the healthcare sector (patients, physicians, medical staff, and healthcare organisation
management) indicated a lack of trust of Cloud solutions. For example, patients'
concern for their medical data being stored at the facilities Cloud service provider is
often reduced due to the pre-existing relationship of trust between patient and doctor
and due to the higher valuation of the patient’s health over data protection and
cybersecurity. In the case of medical staff, they tend to be less aware of cybersecurity
and data protection. Therefore, it is a challenge to raise awareness for security-related
topics and train in new authentication or identification technology. Also, human
resources do nοt need to necessarily understand security and technologies- however
they should be aware of the offerings of the Cloud providers in terms of that expertise.
Without training and education, the occurrence of human errors and social engineering
attacks is more likely.
 Lack of security and technology expertise: Moving the entire IT infrastructure or

individual services from on site to the Cloud requires human resources that understand
Cloud technologies and the associated security and data protection aspects. These
knowledge requirements may not be covered by the same IT personnel responsible for
the on-site infrastructure and eventually result in job termination. To migrate back from
the Cloud to on-site infrastructure may be more challenging under such circumstances.
Furthermore, the demand for Cloud security experts for the healthcare sector is higher
than its supply, hindering Cloud computing advancement.
 Cybersecurity investment is not a priority: A lack of healthcare organisation

management support or restricted public financing results in less financial support to
further promote the digitalisation and to increase cybersecurity and data protection
maturity in the healthcare sector.
 Proving regulatory compliance of the CSP: In several cases, Cloud customers

have difficulty identifying which Cloud service provider is compliant with their set of
legal requirements which sometimes limits their options for CSP collaboration.
Assessment by the cloud customer of the Cloud provider’s compliance is rarely
possible or only with considerable financial resources. However, many CSPs provide
this publicly via their compliance websites, and is often backed up from independent
3rd parties or even, sometimes, through government certification/assurance programs.
In the other hand, regulatory requirements are so complex when it comes to
healthcare-related data that CSPs do not even include these types of customers in
their business model.
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January 2021
 Integration of Cloud with legacy systems difficulties: The integration of Cloud

solutions with already existing healthcare organisation infrastructure or connecting
several devices in-house and cross border, involves a great challenge and even results
in refraining from using Cloud services. Moreover, in most cases, legacy systems are a
part of health IT infrastructure. These systems are not supported by updates from their
suppliers, which complicates integration and interoperability with new technology.
Consequently, this makes these systems vulnerable to cybersecurity attacks. Hybrid
deployment models allow a mix of health IT systems to partner with CSP
services/solutions to deliver the most customizable needs to health care organisations.
At the same time, the cost of deploying extra security features or integrating security
elements with the on premise security perimeter is very high.
3.2 DATA PROTECTION CHALLENGES IN THE CLOUD

Similarly, in this section we present the main data protection-related challenges as derived from
interviews with experts focusing mostly on the technical requirements for Cloud services in
healthcare:
 Privacy by design techniques: The healthcare provider needs to understand whether

the Cloud provider has followed a privacy-by-design approach (both policies and
measures) when developing and deploying the service. The GDPR introduces a legal
requirement on privacy by design and by default for both data controllers and data
processors. Some of the techniques mentioned are minimising the processing of
personal data, pseudonymising personal data as soon as possible, transparency with
regard to the functions and processing of personal data, enabling the data subject to
monitor the data processing and enabling the controller to create and improve security
features. Such approaches and strategies can be achieved through the use of
particular technologies and policies, such as authentication, attribute-based
credentials, secure private communications, anonymity and pseudonymity, statistical
disclosure control, privacy preserving computations, and others18.
 Data management: Healthcare organisations as authorised parties (after receiving

consent) collect, structure and manage patient data. In some cases the information is
automatically transferred to the Cloud (i.e. from a medical device) or it is input by a
delegated party (i.e. medical practitioner). Depending on the type of service in the
Cloud, the input information might be created by a different actor making accuracy of
information a great issue. Controls for ensuring data accuracy should be in place, even
if performed by third parties. Organisations need to establish their own data
governance model/frameworks for understanding what kind of data is the most
sensitive and then applying the required level of controls. Another issue to consider is
interoperability, specifically for healthcare. This is a sector where Cloud computing
brings many benefits due to its flexible range of services.
 Data deletion: It is extremely important to be able to erase data after retention time
has expired, but also upon data subject’s request without undue delay. The data
subjects can substantiate their requests with one of the grounds foreseen in GDPR,
such as when the data is no longer necessary for the initial purpose or when the data
subject withdraws consent. Cloud providers have partially addressed the issue of
identifying storage areas of chunks of information (data tagging). However, effective
deletion of data is still a technical challenge.
 Data portability: This challenge goes hand in hand with vendor lock-in, the most
common risk regarding Cloud Computing. Data portability refers to the transfer of one’s
18
https://www.enisa.europa.eu/publications/big-data-protection
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January 2021
data from one provider to another without loss upon their request. For healthcare
certain standards are in place (like HL7) to ensure interoperability and thus portability.
 Encryption: One of the most important and at the same time difficult measures to
implement is encryption. It is important to ensure secrecy and integrity but it has to be
applied in all the different channels of data transfer and storage. Encryption measures
need to be implemented at both client and server level but also in the channel that
connects them. Responsibility then resides in both the Cloud customer and the Cloud
provider and has huge implications from a technical and legal perspective. At the same
time, few CSPs share the encryption keys with their customer leaving full control to the
provider.
3.3 CYBERSECURITY THREATS

Following the threat taxonomy of ENISA’s procurement guide19 (ENISA, 2020), this section
shows how the specific cybersecurity in healthcare can have implications for Cloud services.
Table 2: Cybersecurity Threats in healthcare and implications for Cloud services
High-level threat Threat Description
Natural forces affect the Cloud infrastructure and eventually

could result in a destruction of relevant systems, network
Natural phenomena Fire, floods or earthquakes
components, or devices. Although the threat probability is low,
the impact might be huge.
The Cloud services’ availability is highly dependent on the Cloud

service provider. Bankruptcy of the Cloud service provider, for
instance, may threaten the continuous availability of the Cloud
service, which may cause operational outages of healthcare
Supply chain failure Cloud service provider failure organisations due to service failure. In the case of the Cloud
provider’s failure, a lack of data export and portability may result
in loss of data. For all supply chain threats, redundancy and
resiliency are critical topics the healthcare organisations should
consider and inquire about.
Network connection is crucial to access Cloud services. A

network failure may impact Cloud-based healthcare service
Supply chain failure Network provider failure
provision and affect the collaboration between different internal
and external partners.
Power supply can affect the Cloud service's availability, which

Supply chain failure Power supply failure
may be critical when a pacemaker's data cannot be observed.
Logs of activities in the Cloud service enable accountability,

serve as evidence in the event of security incidents, and are used
Lack of tracing back to investigate the causes of security incidents. The Cloud
Human errors
functionality customer needs to ensure that logging is enabled based on risk.
It also provides transparency for patients in the case of electronic
health records.
Cloud users may gain unauthorised access to data due to

insufficient access management or lack of awareness, which
Unauthorised data access
Human errors causes unintentional data disclosure. For example, a Cloud-
(information leakage)
based electronic health record has more users than a
telemedicine solution.
Nowadays, the bring-your-own-device policy is widely applied in

the healthcare sector, which causes variation in endpoint
Human errors Non-compliance security. Measures to secure endpoints need to be adopted, and
impacts on compliance, especially for accessing electronic health
records, should be analysed.
19
https://www.enisa.europa.eu/publications/good-practices-for-the-security-of-healthcare-services
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January 2021
Entering incorrect data into a healthcare system can result in loss

of integrity and data disclosure to unauthorised users, such as
Human errors Unintentional change of data
uploading medical documents to the wrong electronic health
record.
If data is not appropriately deleted from a Cloud storage or the

backup media, the data may be accessed later by another Cloud
Errors by Cloud service customer of the same Cloud provider, and eventually result in a
Human errors
administrators/support staff data breach. Configuration errors by Cloud service support staff
may also leave vulnerabilities unpatched and leave entry points
open for malicious attackers.
Cloud environments are susceptible to malware injection attacks,

which are a subcategory of web-based attacks. Attackers exploit
vulnerabilities of a web application and embed malicious code
Malware injection attacks (i.e.
Malicious action into the normal action course. All Cloud service models are
virus, ransomware, worms)
equally vulnerable to this kind of malicious action. Once the
malicious code is executed, the attacker may eavesdrop,
manipulate or steal data and instigate further attacks.
Hijacking infrastructure of the Cloud service provider to mine

cryptocurrency (crypto-jacking) or a medical device (med-jacking)
affects the patient’s safety or the performance of the Cloud
Malicious action Hijacking service healthcare provision. Hyper-jacking refers to hijacking the
hypervisor using a virtual machine-based rootkit. Successful
compromise of the hypervisor grants access to the entire
machine and allows the compromise of the virtual machine.
Social engineering attacks to steal user credentials for SaaS

solutions through phishing, spam, or spear-phishing emails are
always targeted at the weakest link in the security chain, the
Social Engineering attacks i.e. human. On the whole, the healthcare sector is commonly known
Malicious action
Phishing as less IT savvy and this raises the exposure to cyberattacks.
Strong authentication provided by the Cloud service provider
helps to prevent these kinds of attacks. Successful attacks could
result in data breaches, data leakage, or data theft.
Account hijacking results from a malicious attacker gaining

access to privileged accounts or sensitive accounts, such as
Malicious action Account hijacking20 Cloud service accounts or subscriptions. This threat can result in
severe disruption of Cloud services and the provision of
healthcare services.
A Cloud computing environment provides user interfaces and

APIs to interconnect devices and interact with the Cloud service.
Insecure interfaces and
These interfaces offer an entry point for malicious attackers if
Malicious action application programming
they are poorly designed and lack security measures such as
interfaces
encryption and access control. Broken or hacked API’s may
result in data breaches.
Insiders can be current or former employees of healthcare

organisations, contractors, or other trusted partners, who gain
Malicious action Insider threat access from the inside of an organisation. These parties have
had authorized access and may negatively affect the Cloud
service and ultimately result in a data breach.
In shared environments, errors or attacks may provide one tenant

with access to another tenant's resources or data. A malicious
Isolation failure (Multi-
Malicious action attacker may gain access to one specific Cloud customer's
tenancy)
resources or data or even all Cloud customers resulting in data
breaches.
20
Cloud Security Alliance, 2020
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January 2021
Common examples of Cloud computing resource misuse are

launching denial of service attacks, mining cryptocurrency,
Abuse of Cloud computational starting to propagate phishing or spam emails, and hosting
Malicious action
resources malicious content in the Cloud environment. The abuse may
affect Cloud services’ availability or performance harming a
patient’s health.
Denial of service attacks against the Cloud service overload its

resources due to a flood of requests originating from many
Malicious action Denial of service
sources and cause its unavailability and inability to process
requests.
In a Cloud architecture model, data is transferred from the Cloud

Intercepting data in transit
Malicious action customer to the Cloud service provider. During transition, it may
(Man-in-the middle attack)
be intercepted and eventually result in a data breach.
Vulnerability in mobile apps running in the Cloud may also leave

entry points open to be exploited by malicious attackers and
Malicious action Mobile application attacks21
result in data disclosure to unauthorised persons or even data
loss.
Technical failures of network-related components influence the

availability of Cloud service. Examples include the loss of Internet
connectivity due to failures at the Cloud customer’s or service
provider’s site, a temporary reduction of network bandwidth at the
Network-related technical
System Failure Cloud customer’s internet service provider, which affects the data
failures or attacks
transfer from and to the Cloud service provider, and disruptions
in the global Internet routing infrastructure capping the
connection between the Cloud customer and Cloud service
provider.
Insufficient patch or life cycle management may occur at the

Cloud customer's and the Cloud provider's sites. Failing to
Insufficient maintenance and maintain the Cloud infrastructure and leaving software unpatched
System Failure
maintenance procedures may result in disturbances or even failure of the Cloud service.
Eventually, the patient's health may be affected due to
unavailable medical records.
Due to errors, software failure can affect the Cloud services or

System Failure Software failure medical device data availability and eventually endanger patient
safety.
Failure of IT hardware at the Cloud service provider's or

customer's site, limiting the Cloud service's availability, may
System Failure Hardware failure severely impact patients' health in emergency cases.
A medical device failure affects real-time data availability in the
Cloud service possibly harming the patient's health.
Technical failure related to system misconfiguration or

Deployment/ configuration interoperability issues in deployment. A cloud migration is a data
System Failure
Error centre migration, and it brings along all of the complexities that
traditionally go along with one.
21
OWASP, 2016
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January 2021
4. USE CASES
In this section, three use cases of Cloud services for healthcare are shown, including a
reference Cloud architecture, factors to be considered during risk assessment, and risk
mitigation measures.
4.1 USE CASE 1 - ELECTRONIC HEALTH RECORD

An electronic health record (EHR) provides services to a wide range of potential users: patients,
doctors, nurses, public health officials, and more. These systems collect, store, manage and
transmit sensitive health data such as patients’ contact details, social insurance numbers,
medical examinations’ results, pathologies, allergies, diagnosis, and treatment plan. Healthcare
professionals are provided with an overview of the history and the status of the patients’ health
and can access it if needed from pre-defined terminals within the healthcare provider’s
premises. After each examination or consultation, patient records are updated with the latest
data by the treating doctor or nurse either by scanning paper-based documents or manually
diagnosing and treatment plans.
Paper-based documents containing patient data are increasingly replaced with EHR in many
countries, allowing health information to be shared in an easy-to-use and standardised way
between different stakeholders such as healthcare professionals and patients. Solutions in this
area often involve the use of Cloud computing resources or partially Cloud-based components.
Patients can access and manage their EHR through a patient portal, which is usually integrated
into Cloud solutions22.
Figure 1: Cloud Architecture Model - Electronic Health Record (EHR)
22
This is an exemplar case as not every EHR deployment uses governmental Clouds provided by the respective ministry. It
is very common to see regional EHR deployments operated on public or private Clouds by public or private EHR providers.
An EHR is typically sourced as SaaS and not at IaaS level but for the sake of completeness in this report, the specific
service model is selected for the EHR.
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OVERVIEW
Service Model IaaS Deployment model Governmental Cloud
The healthcare organisation network is the Cloud customer of

the governmental IaaS Cloud service provider. It is the body
responsible for developing, maintaining, and deploying the
application for sharing electronic patient records. Healthcare
organisations upload the patient EHRs either through the web
Healthcare organisation network
application or through an API, connecting their clinical
information system with the corresponding national data centre
in the Cloud. EHRs are stored at the national datacentre.
Patients access their health records through the web
application.
The ministry of health, a government institution, provides the

physical infrastructure for storing the EHRs. That includes,
Cloud service provider
amongst others, the maintenance of the network infrastructure
and the underlying operating systems.
DEFINITION OF PROCESSING OPERATION AND ITS CONTEXT

Contact information (patient’s last and first name, address, telephone number, email address),
contact information of relatives for emergency cases, social insurance number, medical
Personal data processed appointments, medical examination results, pathologies, allergies, diagnosis and treatment
plans (medical information), administrative and financial information (invoices, hospitalisation
papers, etc.).
Provision of healthcare services (diagnosis, treatment, hospitalisation), treatment planning and

Processing Purpose
billing
Data Subject Patients, relatives, doctors, nurses
Recipients of the Data Doctors and nurses, administration and accounting department, public health system, patients
Data Processor IaaS Cloud service provider
ASSESSING CYBERSECURITY RISK IMPACT

When conducting a risk assessment for similar use cases, healthcare organisations should take
into account the possible impact of a cybersecurity incident on confidentiality (e.g. data breach
leading to exposed patient data), integrity (e.g. alteration of important patient data) or availability
(e.g. timely access to patient data during emergency treatment). This would allow the healthcare
organisation to assign an appropriate quantitative or qualitative value to the risk impact
depending on the specific risk assessment methodology used. A brief description of factors to
be considered for risk impact assessment is listed below:
Factor Description
Within the scope of the specific processing operation, the impact from loss of confidentiality is considerable
Confidentiality given the nature of sensitive information included in the EHR. Data subjects could be expected to encounter
significant adverse effects from unauthorised disclosure of their health data.
The impact in case of loss of integrity should be considered particularly if the EHR includes important patient
data that may be used to influence medical decisions. Data subjects may encounter significant or even
Integrity
irreversible consequences from unauthorised alteration of health data (signals and statistics), which could
even make it difficult for them to receive appropriate treatment.
Depending on the nature of data included in the EHR and the context of their use, loss of availability may also
Availability be of significant impact. Inability to access the patient’s EHR may hinder timely and accurate treatment of the
data subjects, even putting their lives at risk.
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January 2021
ASSESSING RISK LIKELIHOOD

The table below describes how the main Cloud security threats may be relevant for the
reference Cloud architecture and the specific use case. Healthcare organisations should use
the information below when assessing the likelihood of a cybersecurity risk. It should however
be noted that the descriptions below only refer to the described use case and additional factors
related to the operational context of the healthcare organisation should be considered before
determining the risk likelihood.
Threat Description
Natural Typically, in such use cases the servers are located in data centres enforcing a suitable level of physical
phenomena security requirements, which tends to reduce the respective risk likelihood. Such data centres usually obtain
certificates that show that they are protected against fire, water, or earthquakes and the existence of such
certificates should be factored in the risk likelihood assessment.
Supply chain As the infrastructure is outsourced to Cloud providers the likelihood of this risk tends to be reduced. The failure
failure of power supply or other Cloud service disruptions is less likely because the providers are specialised in
maintaining their services. However, even big Cloud platforms are not entirely immune to outages of their Cloud
infrastructure.
Human error An undefined number of employees may be performing personal data processing, and there is no clear policy
regarding granular access to health records. This should be considered as a factor that increases risk
likelihood. Human actors' common mistakes in this use case are the usage of default or weak passwords, lack
of access control to sensitive data, non-compliance with security policies, or the possibility of human error.
However, the obligations of all parties involved in the process should be clearly defined, and awareness-raising
seminars should be organised periodically.
Malicious Many parties such as healthcare organisations, patients, and public health officials are strongly interconnected in
actions this Cloud system, which is difficult to isolate from malicious actors completely. Malicious attackers may also be
internal actors who might have direct or indirect access to the Cloud services. Potential attacks in this area might
involve social engineering (e.g., phishing), theft, espionage, malware (e.g., ransomware), or denial of service
attacks. A database containing electronic health records of almost every citizen in a specific country stored
centrally may be an attractive target for malicious attackers. On the other hand, Cloud service providers can
bundle the knowledge of internal and external security experts, which allows them to enforce security measures
more efficiently than proprietary data centres. These factors and especially the operational context of the
healthcare organisation and the Cloud service provider should be assessed when determining the risk likelihood.
System Software might have errors that cause the service to fail and become unavailable. The EHR is a very central
failures solution to share patient information and is even legally regulated and requires security certification in most
countries, reducing the occurrence probability. The government infrastructure typically also supports relevant
governmental services that require a stable availability of the services. It can therefore be assumed, that the
probability of system failures, especially hardware is usually relatively low. However, statistics on system
failures or SLAs from the Cloud service provider can provide a more accurate source of data to feed into the
risk assessment study.
4.2 USE CASE 2 – REMOTE CARE

Remote care (as part of Telemedicine) supports remote patient-doctor consultation and has
been increasingly used in recent times due to the pandemic and its circumstances. During
COVID-19, remote care/consultation has been a safe way to provide expert care and advice
lowering infection risk. In some countries, remote care is an established approach to overcome
centralised healthcare infrastructure and large distances. In this use case, we consider a service
provider that offers a video call platform for communication between health professionals and its
patients, individually or in group sessions. The service also offers recording, analysis, and
transcription of the calls to assist the health professionals with medical evaluations, diagnosis,
and documentation.
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January 2021
Figure 2: Cloud Architecture Model – Remote Care
OVERVIEW
Service Model SaaS Deployment model Public Cloud
The healthcare organisation uses a telemedicine (including audio and video) application for its
doctor-patient consultation. The communication service is offered as a web and mobile
Healthcare organisation
application. The healthcare professionals connect over the internet using a client to access the
Cloud service. Patients connect over the internet using either their computer or mobile phone.
The Cloud service provider is a communication technology company offering a SaaS

Cloud service provider communication service. Its responsibility includes application development, maintenance, and
providing the underlying infrastructure.
Contact Information (last and first name, nickname), video recordings, transcriptions of
Personal data processed
recordings
Processing Purpose Provision of healthcare services (patient-doctor consultation)
Data Subject Patients/Medical professionals
Recipients of the Data Medical professionals
Data Processor SaaS Cloud service provider
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(e.g. timely access to patient data). This would allow the healthcare organisation to assign an
appropriate quantitative or qualitative value to the risk impact depending on the specific risk
assessment methodology used.
A brief description of factors to be considered for risk impact assessment is listed below:
Factor Description
Within the scope of the specific processing operation, the impact from loss of confidentiality can be
considerable as the primary focus of such use cases involves the direct exchange of patient data. Data
Confidentiality
subjects may therefore encounter significant adverse effects from unauthorised disclosure of their health
data.
The impact of the loss of integrity will depend on the nature of the telemedicine/remote care application. For
non-critical consultation applications the impact may not be as significant, but depending on the context,
Integrity alteration of medical data could have high-impact consequences. Data subjects may encounter significant or
even irreversible consequences from unauthorised alteration of health data (signals and statistics), which
could even make it difficult for them to receive appropriate treatment.
Assessing the impact of loss of availability heavily depends on the context of the telemedicine/remote care
application. This may range from low in the case of standard consultations for which alternative methods of
Availability
communication can be used to very high in the case of emergency interventions of medical staff using the
telemedicine platform.

The table below describes how the main Cloud security threats may be relevant for the
reference Cloud architecture and the specific use case. Healthcare organisations should use
the information below when assessing the likelihood of a cybersecurity risk. It should however
be noted that the descriptions below only refer to the described use case and additional factors
determining the risk likelihood. Similarly the underlying telecommunications infrastructure-
backbone would be a risk factor, however not in the scope of this assessment.
Threat Description
Natural Typically, in such use cases, the servers are located in data centres enforcing a suitable level of physical
certificates should be factored into the risk likelihood assessment.
Supply chain As the infrastructure is outsourced to Cloud providers the likelihood of this risk tends to be reduced. The
failure failure of power supply or other Cloud service disruptions is less likely because the providers are
specialised in maintaining their services. However, even big Cloud platforms are not entirely immune to
outages of their Cloud infrastructure.
Human error (Video)Conferencing tools are considered standard IT equipment which makes it more likely that users are
familiar with this technology and the relevant interfaces. Especially during the pandemic situation, the
adoption of and familiarisation with videoconferencing solutions has increased significantly. Still, the risk
may be higher when medical staff are less familiar with or un-trained in the use of such tools.
Malicious During the pandemic, many stakeholders have switched to remote conferencing and telemedicine, which in
actions turn has led to such solutions becoming more attractive targets. Healthcare organisations also extended the
use of teleconsultation. Potential attacks in this area might involve social engineering (e.g. phishing), theft,
espionage, malware (e.g. ransomware), or denial of service attacks.
System Videoconferencing technology has been developed and improved for a long time, resulting in well-
failures established software solutions. Nevertheless, software failure might still happen with low likelihood since
Cloud has enough redundancy.
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January 2021
4.3 USE CASE 3 – MEDICAL DEVICES

Medical device data is made available to different stakeholders using Cloud technology to
enable remote patient monitoring e.g. for heart disease or diabetes patients. Medical device
manufacturers also provide medical device monitoring using Cloud computing technology.
In this use case, we consider a medical device manufacturer that produces a device to measure
certain patient data (e.g. a pacemaker measuring heartbeat). The device itself is not able to
communicate over the internet. However, it can transfer measurements via Bluetooth to
smartphones with an appropriate app from the device manufacturer. The app can then transfer
the aggregated measurements for a month to a Cloud file storage provider and share this
information with the treating doctor.
Figure 3: Cloud Architecture Model - Medical Device
OVERVIEW
Service Model PaaS Deployment model Private Cloud
The healthcare organisation offers its patients a medical device (e.g. pacemaker) that is
Healthcare organisation connected to their mobile device. Healthcare professionals can access the measured data over
the internet using their clients.
The medical device manufacturer offers a Cloud service for patient measurements (e.g.
measuring heartbeats) to healthcare organisations. The medical device manufacturer provides
Medical device manufacturer the application and the device and ensures the connection to the Cloud service provider through
APIs for data transfer. It uses PaaS to securely develop and deploy the software, including
sending emails with individualised links containing the uploaded aggregated measurements.
The Cloud service provider provides the application platform, including application interfaces
Cloud service provider and the underlying Cloud infrastructure that includes network, servers, operating systems, and
storage.
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Personal data processed Contact information (last and first name), health data (e.g. heartbeat) measurements
Processing Purpose Provision of healthcare services (e.g. sharing heartbeat measurements)
Data Subject Patients
Recipients of the Data Medical professionals
Data Processor PaaS Cloud service provider

(e.g. timely access to patient data). This would allow the healthcare organisation to assign an
appropriate quantitative or qualitative value to the risk impact depending on the specific risk
assessment methodology used. While this specific use case only involves collection of patient
data that is then subject to examination by medical staff, other use cases involving medical
devices may include the device itself taking actions based on measurements, resulting in a
drastically different risk profile. A brief description of factors to be considered for risk impact
assessment is listed below:
Factor Description
Loss of confidentiality for similar use cases may cause data subjects to encounter significant adverse effects
from unauthorised disclosure of their health data. Within the scope of the specific processing operation, the
impact from loss of confidentiality is not necessarily considered critical since the disclosure of
Confidentiality measurements such as heartbeats is usually not as severe as disclosing other health data. However if the
data is exchanged in its entirety through unsecure means (i.e. email) poses a risk in itself. In a broader
context, the impact of loss of confidentiality for use cases involving medical devices depends on the nature
of the data involved in the operation.
In the case of loss of integrity, data subjects may encounter significant or even irreversible consequences
from unauthorized alteration of health data. For instance, doctors may prescribe inappropriate medication.
This impact is heavily influenced by the overall treatment process; for instance, a doctor might notice
Integrity sudden deviations from regular measurements and doctors usually explain treatment procedures or
changes in medication via personal conversations, which might reveal the alteration of data. In the case of
more automated processes or even processes where the device can even act based on the data, the impact
of loss of integrity may be significantly higher.
The impact of loss of availability may range from moderate to critical depending on the frequency by which
the measurements need to be made available to medical staff or even the nature of the measurements (e.g.
Availability
when an anomaly in measurements may indicate a life threatening circumstance). The lack of data may
affect the patient’s health because unavailability affects intervention options.

The table below describes how the main cloud security threats may be relevant for the
reference cloud architecture and the specific use case. Healthcare organisations should use the
information below when assessing the likelihood of a cybersecurity risk. It should however be
noted that the descriptions below only refer to the described use case and additional factors
determining the risk likelihood.
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January 2021
Threat Description
Natural Typically, in such use cases the servers are located in data centres enforcing a suitable level of physical
certificates should be factored into the risk likelihood assessment.
Supply chain As the infrastructure is outsourced to Cloud providers, the likelihood of this risk rends to be reduced. The
failure failure of power supply or other Cloud service disruptions is less likely because the providers are specialised
in maintaining their services. However, even big Cloud platforms are not entirely immune to outages of their
Cloud infrastructure.
Human error The medical devices need to be configured and require patches. The lack of patches or adequate
configuration, procedures, or processing errors may leave the device vulnerable to cyberattacks.
Malicious The system handles patients' private information, which might be interesting for malicious actors. Malicious
actions attackers may also be internal actors who might have direct or indirect access to the Cloud services. Potential
attacks in this area might involve theft, espionage, malware (e.g., ransomware), or denial of service attacks.
On the other hand, Cloud service providers can have access to the knowledge of internal and external
security experts, which allows them to enforce security measures more efficiently than proprietary data
centres. These factors and especially the operational context of the healthcare organisation and the Cloud
service provider should be assessed when determining the risk likelihood.
System Medical devices undergo an extensive certification process that should impact occurrence probability
failures positively. The software to access the health data may be subjected to failures, but security requirements are
relatively high to ensure patient safety. Network and IT hardware failure may occur and depends heavily on
the location. However, there is very low probability for system failures due to the multi tenancy and
redundancy the Cloud services offer.
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5. CLOUD SECURITY
MEASURES
This section provides a set of guidelines for ensuring cybersecurity and data protection for the
healthcare sector’s Cloud customers procuring and eventually providing Cloud-based
healthcare services. The security measures are based on common frameworks for Cloud
security such as BSI C5 and ANSSI Cloud recommendations, but also the ongoing work on
Cloud certification. This section contains the security measures with corresponding references
to the good practices of ENISA’s procurement guide and the use cases.
5.1 CLOUD SECURITY MEASURES AND GOOD PRACTICES

In general, the Cloud security measures, and the corresponding responsibility depend heavily
on the chosen service and deployment model.
Each Cloud security measure entails:
 a reference to the good practices of the Procurement Guide (ENISA, 2020),

 a reference to the use case, for which the measure is applicable,
 an indication of the responsibility per use case and
 additional data protection considerations.
The last item relates to how each security measure eventually satisfies a potential data
protection requirement and shows how through this measure acceptable implementation of the
requirement is met. Some use cases require stronger data protection measures due to the
criticality of the data and the evaluated risk. These enhancement considerations are attached to
the Cloud security measures where applicable.
SM-01 Identify security and data protection requirements
Involve necessary stakeholders such as risk, legal, compliance, or IT department in the procurement process. Requirements
solicitation should entail regulatory compliance.
Investigate and identify requirements such as:
 local legislation and pan-area legislation for cloud security, cybersecurity and data protection
 internal requirements such as information security policies
 legal requirements which apply to a specific healthcare product, for instance, countries enforce specific security and
data protection requirements for electronic health records.
 security and data protection requirements of the governmental Cloud service provider.
Check and assess legal requirements for data protection, cybersecurity, and Cloud security. Reconcile legal requirements with
the security controls of the Cloud service provider. In this case, it would be essential for the health care organisation to tag and
assign data based on sensitivity levels, and ensuring that is provided to the CSPs so they can assign higher or lower levels of
controls depending on the data.
Request evidence from the Cloud provider such as certification from third-party auditors to ensure the Cloud provider's adherence
to recognised standards.
Ensure that responsibilities for ensuring compliance between the Cloud customer and Cloud service provider are identified and
understood.
Address security and privacy requirements in the service level agreement between the Cloud customer and the Cloud service
provider. Require proof from the CSP for ensuring compliance with the requirements.
Reference to Good Practice Procurement GP 1. Involve the IT department in procurement
29
January 2021
Use Case 1 Use Case 2 Use Case 3

Application to Use Case
x x x
Cloud Customer x x x
Responsibility
Cloud Service Provider
Preserve the right of data subjects taking into account:

 the obligation to provide information on the ground for data processing;
 data subject’s consent for the processing
 the right to access data
 the right to data minimisation (only the information required)
Additional data protection considerations  the right to rectification and erasure

Require data storage within the country of the HCO.
Ensure privacy by design principles are followed both for the HCO and the CSP
based on the service model followed.
Cloud customer must ensure that data is securely transferred and verified at a
safe location before the cloud provider could permanently delete the data. The
cloud customer should be responsible for this timely data transfer and the
contractual needs to allow for a proper transfer.
SM-02 Conduct a risk assessment and data protection impact assessment
Conduct a risk assessment according to national guidelines or following a well-known methodology (find some here23) to identify
cybersecurity and data protection threats and risks for new Cloud services and evaluate the impact on the overall IT security risk
Conduct a data protection impact assessment when procuring Cloud services (ENISA tool for evaluating the risk of personal data
processing operation24)
Ensure alignment with the healthcare organisation’s risk appetite by identifying and implementing controls to mitigate identified
risks to the organisation’s risk acceptance level, by refraining from procuring the Cloud service or choosing another provider.
Monitor the risk landscape continuously to be able to identify emerging risk or to enforce further controls.
GP. 11 Conduct a risk assessment as part of the procurement process

Reference to Good Practice Procurement GP. 19 Conduct data protection impact assessment for new products and
services

x x x
Responsibility
Additional data protection considerations none
23
https://www.enisa.europa.eu/topics/threat-risk-management/risk-management/current-risk/business-process-
integration/the-enisa-rm-ra-framework
24
https://www.enisa.europa.eu/risk-level-tool/risk
30
January 2021
SM-03 Establish processes for security and data protection incident management
Ensure that an incident response plan defines the actions to be taken after a security incident has occurred at the Cloud service
provider. The Cloud service provider should have a process for handling security incidents according to European or national
legislation.
Identify the responsibilities of Cloud customers and Cloud service providers in the case of a security or data protection incident.
Ensure that internal measures, processes, and roles are in place and aligned with the Cloud service provider’s security
provisions.
Test security incident processes in collaboration with the Cloud service provider and verify how a security incident can be
reported to the Cloud service provider.
Request reports from the Cloud service provider for detected security incidents and the status monitoring of reported security
incidents by the Cloud service provider.
Ensure SLA contains at least performance indicators of defined availability and capacity of the Cloud service, response and
reaction times of the Cloud service provider’s service organisation, notification of predefined maintenance or other planned
downtime, and occurred security incidents either by default or on request.
GP 22. Develop incident response plans

Reference to Good Practice Procurement
GP 23. Involve vendor/manufacturer in incident management

x x x
Cloud Customer x x
Responsibility
Cloud Service Provider x x x
Ensure Ensure Ensure patients are

patients/customers are patients/customers are informed if their data
informed if their data informed if their data has been subjected to a
has been subject to a has been subject to a security incident.
security incident. security incident.
Ensure legal obligations
Ensure legal obligations Ensure legal obligations to notify are met.
to notify are met. to notify are met.
Additional data protection considerations For Cloud customer:
For Cloud customer: ensure the contact
ensure the contact person at the Cloud
person at the Cloud service provider is
service provider is reachable 24/7 and
reachable 24/7 and response is guaranteed
response is guaranteed within a predefined time.
within a predefined time.
SM-04 Ensure business continuity and disaster recovery
Ensure the Cloud provider notifies planned downtime several days in advance.
Define processes for business continuity and identify the Cloud service provider’s and Cloud customer’s responsibility in the event
of a service disruption. Ensure the Cloud service provider has an effective business continuity management plan (based on best
practices or national guidelines).
Test the business continuity process and ensure that key roles are familiar with their tasks.
Define and document procedures and responsibilities for critical operations that can damage assets stored in the Cloud
computing environment.
Examples of the critical operations are:
 installation, changes, and deletion of virtualised devices such as servers, networks, and storage;
 termination procedures for Cloud service usage;
 backup and restoration.
Ensure monitoring of these operations by a supervisor.
Disaster recovery and data restore
31
January 2021
Identify disaster recovery and data restore requirements of the healthcare organisation. Assess whether the Cloud service needs
provision from two separate locations that give each other redundancy.
Ensure disaster recovery and restore processes of the Cloud service provider are aligned with these identified requirements.
Identify the emergency contact of the Cloud service provider.
Request a test protocol from the Cloud service provider that shows successful disaster recovery and data restore process testing.
Backup
Ensure adequate backup (i.e., offsite backup or a multi-Cloud approach) to ensure business continuity in case of Cloud service
provider failure or data loss.
If the event backup is part of the Cloud service, define or identify backup requirements following information security policies and
legal requirements (to ensure compliance).
Request information on the Cloud service provider's backup capabilities and verify that these meet backup requirements.
Implement backup capabilities if the Cloud provider does not provide them, or the requirements are not met.
Reference to Good Practice Procurement GP 6. Establish Business Continuity plans

x x x
Responsibility
Cloud Service Provider x
Additional data protection considerations none
SM-05 Termination and secure data deletion
The Cloud customer's asset stored on the Cloud service provider's premises should be removed, and returned if necessary,
promptly upon termination of the contractual agreement or if data retention period is met. Proper permanent deletion of data upon
customer’s or data subjects is the full responsibility of the Cloud provider.
Data deletion
Ensure data is deleted according to recognised standards or techniques, meaning permanently and irretrievably deleted, and
taking into account backup and log data.
Termination
Request a description of the termination process, disposal and return of Cloud customer’s asset and reuse of resources from the
Cloud service provider.
Ensure the description contains a list of all the assets and documents the schedule for the termination of service, which should
occur promptly.

x x x
Cloud Customer
Responsibility
All necessary measures to ensure data deletion should be in place and

documented in data retention policy (including technical means to support data
stored in several systems). The policy should also include cases of data
Additional data protection considerations
replication (storage in multiple sites) which would mean enabling tracing of the
data to ensure complete deletion. Client-side encryption versus server-side
encryption could be a solution to this25.
25
https://www.enisa.europa.eu/publications/privacy-and-security-in-personal-data-clouds
32
January 2021
SM-06 Auditing, logging and monitoring
Define or identify requirements for event logging (for instance, audit trails for patient to control access to their EHR, retention of
logs) and verify if the Cloud service provider meets those requirements.
Determine and evaluate the adequacy of the Cloud service providers logging capabilities for privileged operations. Ensure
privileged operations delegated to the Cloud service provider are logged, and the Cloud service provider provides corresponding
log reports on request. Request documentation from the Cloud service provider of service monitoring capabilities and ensure the
monitoring data is consistent with event logs and SLA terms.
Ensure that the Cloud service provider meets the agreed capacity requirements through continuous monitoring. Monitor and
forecast the use of Cloud services to promptly communicate changes in capacity to the Cloud service provider and ensure quick
adjustment.
Implement additional logging capabilities to close the gap between the Cloud service provider's logging capabilities and the Cloud
customer’s requirements.
Ensure data retention for log data follows legal requirements. Ensure log data is also deleted in the case of termination or change
of provider.
Auditing the Cloud provider is a rather cumbersome task for the healthcare organisation to take over; auditing takes place at
specific intervals to ensure compliance and certification maintenance.
Reference to Good Practice Procurement GP 9. Allow auditing and logging

x x x
Responsibility
Additional data protection considerations none none none
SM-07 Implement vulnerability and patch management
Identify the scope of responsibility for technical vulnerability management and patch management. Determine and set up
processes for vulnerability management and patch management in scope.
Request specifications of the cloud service provider’s vulnerability and patch management practices that affect the Cloud service.
The Cloud service provider should give evidence of regularly performed technical assessments such as penetration tests or
vulnerability scans either by default or at the Cloud customers request. Conduct or request security testing in the event the cloud
service provider cannot provide evidence, or the application has not been tested.
GP 2. Implement a vulnerability identification and management process

GP 5. Establish testing policies

x x x
Cloud Customer x x
Responsibility
33
January 2021
SM-08 Manage assets and classify information
Include information and assets stored in a Cloud environment in the asset inventory. Indicate where the data is stored, i.e. Cloud
services. Asset changes should be monitored and recorded.
Classify information and data that will be stored or stored in a Cloud environment to meet security requirements.
Align change management process between the Cloud service provider and healthcare organisation. Ensure any change made
by the Cloud service provider is taken into account in the internal change management process.
Identify the data protection levels for data confidentiality, integrity, and availability.
Reference to Good Practice Procurement GP 28. Perform asset inventory and configuration management

x x x
Responsibility
Information should be protected according to the risk assessment or the DP

Additional data protection considerations
impact assessment.
SM-09 Enable data encryption for data at rest and data in transit
Ensure data in the Cloud service provider’s location is encrypted during the whole data life cycle (creation, storing, using, sharing,
archiving, deleting).
Review the Cloud provider’s encryption practices to ensure they meet the required encryption level, are compatible with other
cryptographic protection, and meet regulatory requirements.
Ensure data transfer from and to the Cloud service for all incoming and outgoing connections is encrypted.
(note for the author: Encryption in transit is always a shared responsibility- the Cloud customer needs to take the appropriate
measures to ensure that encryption will function properly (i.e. provider or patient using outdated browsers with known
vulnerabilities in encryption protocols will result into breaking the encryption measures applied by the CSP).
Reference to Good Practice Procurement GP 10. Encrypt sensitive personal data at rest and in transit

x x x
Responsibility
Ensure data at rest Ensure data-in transit is Ensure data at rest

including backup and encrypted. Advise on including backup and
Additional data protection considerations data-in transit is client side encryption. data-in transit is
encrypted. Advise on encrypted. Advise on
client side encryption. client side encryption.
34
January 2021
SM-10 Ensure security of encryption keys
Define security requirements for key management and ensure procedures for key management are implemented.
Identify cryptographic keys for each Cloud service and manage them according to defined requirements and procedures.
In the event the cloud service provider offers key management functionality, request documentation from the Cloud service
provider on the type of keys used, specifications of key management covering procedures for each stage of the key lifecycle such
as generating, changing/updating, string, retiring, retrieving and destroying.
Ensure keys are stored on certified devices (for example, hardware security modules), which ensure the level of protection for the
key material.
Ensure segregation of duties is in place for the key management and is enforced by technical or organisational means.
Ensure a process for recovering encryption keys is in place.
Evaluate an encryption approach (provider- or client-managed key or hold- your-own-key) based on the risk analysis for your data
and business. Where possible, use a client server-managed key.
Reference to Good Practice Procurement GP 10. Encrypt sensitive personal data at rest and in transit

x x x
Cloud Customer x x
Responsibility
SM-11 Data portability and interoperability
Ensure all data is provided in industry-standard format upon request from the Cloud service provider.
Make sure the Cloud service provider uses standardised and secure network protocols for the import and export of the data to
and from the Cloud service.
Interoperability
The Cloud service provider should use open and published API to support interoperability between components and applications.
Ensure the Cloud service provider uses an industry-recognised virtualisation platform and standard virtualisation formats to
support interoperability.
Reference to Good Practice Procurement -

x x x
Responsibility
35
January 2021
SM-12 Client and endpoint protection
Identify all devices such as laptops, mobile devices, medical devices, etc. (endpoints) of your personnel connecting to the Cloud
service.
Ensure that the identified assets are included in the asset inventory.
Define a security baseline for hardening the endpoints according to internal information policies and ensure device configuration
meets the requirements during the whole lifecycle. For example, this could be achieved using a device management solution or
regular assessments of the client’s current state.
Implement technical controls to meet security requirements.
Use tools for facilitating endpoint security offered by the Cloud service provider.
Reference to Good Practice Procurement GP 28. Perform asset inventory and configuration management

x x x
Responsibility
SM-13 Authentication and access control
Ensure access policies specify security requirements for user access to data, application interfaces, systems, and the network or
network components for each Cloud service.
Ensure that access to the Cloud services is secured by strong authentication controls such as multi-factor authentication.
Ensure a process for restoring authentication data is in place.
Determine whether access to the Cloud service, Cloud service functions, and Cloud customer data can be restricted following the
internal access policy.
Reference to Good Practice Procurement -

x x x
Responsibility
Two-factor Two-factor Two-factor

authentication should be authentication should be authentication should be
Additional data protection considerations mandatory for providers mandatory for providers mandatory for providers
and recommended for and recommended for and recommended for
patients patients patients
36
January 2021
SM-14 Information security awareness, education and training
Establish a regular target group-oriented awareness and training programme for all internal (employees) and external actors (Cloud
service providers), which deal with sensitive data such as electronic health records or medical diagnosis. Educate medical staff on
what sort of security benefits CSPs provide in terms of risk reduction, protection of patients health data, etc. Realising that there
are core benefits to outsourcing security where trust and security are intrinsic to the business. More general cybersecurity
awareness around social engineering attacks and good cyber hygiene for medical staff/health care professionals (e.g not always
using the same login and passwords or requiring two factor authentication by default) would all help alleviate common human error.
The target group consists of supervising managers, operational staff, IT personnel, and users such as medical practitioners, nurses,
and patients. Take special care of customers/patients security that is being provided around their data for their peace of mind.
Cover Cloud-related procedures and standards, risks and risk management, risks affecting the system and network environment
when using Cloud services, and legal/regulatory aspects. Best practices and documented guidelines are also recommended to
support the final goal.
GP 21. Provide cybersecurity training on the organisation's security practices to

Reference to Good Practice Procurement staff and external consultants
GP 27. Raise cybersecurity awareness among staff

x x x
Responsibility
SM-15 Network Security
Ensure traffic between untrusted and trusted connections of network environments and virtual instances is restricted and
monitored. This configuration should be reviewed on an annual basis. Implement security measures according to risks identified
including the additional function required: Intrusion Protection System, anti DDoS solutions, WAF, CASB, ATP, Threat
intelligence.
Request information on the security perimeter from the Cloud service provider. Ensure that all allowed services, protocols, ports,
and compensating controls are documented.
GP 15. Determine network requirements

GP 28. Perform asset inventory and configuration management

x x x
Cloud Customer x
Responsibility
Ensure the network is

protected using a
firewall on protection
level, intrusion
prevention and
Additional data protection considerations detection system. none none
Ensure the network is

protected against
denial-of-service
attacks.
37
January 2021
SM-16 Review isolation between tenants
Ensure the Cloud service provider applies appropriate segmentation for data, applications (physical and virtual), infrastructure,
and network between different tenants to restrict one tenant's access to another tenant's resources.
Request evidence from the Cloud service provider of established policies and procedures, isolation of critical assets, and/or
sensitive data.
Make sure to securely configure the provided Cloud infrastructure functionality in order to achieve the required segmentation.
GP 14. Segregate your network

GP 28. Perform asset inventory and configuration management

x x x
Cloud Customer
Responsibility
SM-17 Physical and environmental security
Ensure that the Cloud service provider provides physical security controls to protect data centres and prevent unauthorized
physical access. Controls include physical authentication mechanisms or electronic monitoring and alarm systems.
Ensure that the Cloud service provider restricts its support staff's access to physical resources according to the need-to-know or
least privileged principles.
The Cloud service customer should request certifications that prove that the Cloud service provider's infrastructure is hosted in a
secure data centre.

x x x
Cloud Customer
Responsibility
38
January 2021
6. CONCLUSION
For a number of years healthcare organisations have been contemplating moving part of their
ICT infrastructure and services to the Cloud. Over this period, a number of healthcare-specific
solutions have been developed using a variety of service models and deployment models fit for
purpose. The on-going pandemic has further highlighted the importance of certain healthcare
services that could benefit significantly from a move to the Cloud. The potential improvements in
availability, scalability and reliability of services such as telemedicine, wider deployment and use
of EHR and medical devices for remote patient care come on top of the cybersecurity, economic
and efficiency benefits Cloud services can bring to healthcare organisations.
Yet, the level of adoption of Cloud services in healthcare remains low and generally limited to
administrative processes. A number of factors contribute to this, including lack of trust in Cloud
services, lack of expertise, compliance requirements, particularly in relation to data protection,
and more.
This report aims to help healthcare organisations in taking the next step towards further
adoption of Cloud services. Built around three standard use cases of Cloud services in a
healthcare context, this report highlights the main factors to be considered from a cybersecurity
and data protection standpoint when assessing the relevant risks. The factors can be used in
any risk assessment methodology that the healthcare organisations are currently using.
Moreover, the report proposes a set of security measures for healthcare organisations to
implement when planning their move to Cloud services. These measures cover both
cybersecurity and data protection aspects and are linked to the procurement guidelines for
healthcare organisations previously published by ENISA.
While this report is a step towards supporting healthcare organisations in taking the next step
towards Cloud services it is not enough on its own. Healthcare organisations would require
additional support, such as specific guidance from national and EU authorities, industry
standards on Cloud security, especially in a healthcare context, clear guidelines from Data
Protection Authorities on moving healthcare data to the Cloud and collaboration with Cloud
service providers and medical device manufacturers to develop suitable Cloud solutions.
39
January 2021
7. REFERENCES
AbuKhousa, E., Mohamed, N., and Al-Jaroodi, J., e-Health Cloud: Opportunities and
Challenges, Future Internet, Vol. 4, 2012, pp. 621-645, doi: 10.3390/fi4030621
Agliari, E., Barra, A., Barra, O. A., Fachechi, A., Franceschi Vento, L. & Moretti M., Detecting
cardiac pathologies via machine learning on heart-rate variability time series and related
markers, Sci Rep 10, 8845, 2020, https://doi.org/10.1038/s41598-020-64083-4
Cloud Security Alliance, Top Threats to Cloud Computing – The Egregious 11, 2020.
Cavoukian, A., Fisher, A., Killen, S. et al., Remote home health care technologies: how to
ensure privacy? Build it in: Privacy by Design, Identity in the Information Societey IDIS, Vol.
3, 2020, pp. 363–378, https://doi.org/10.1007/s12394-010-0054-y
Davenport, T., and Kalakota, R., The potential for artificial intelligence in healthcare, Future
Healthcare Journal Vol. 6 No 2, 2019, pp. 94-98. doi: 10.7861/futurehosp.6-2-94
ENISA, Cloud Computing – Benefits, risks and recommendations for information security, 2012.
ENISA, Good Practice Guide for securely deploying Governmental Clouds, 2013.
ENISA, Procurement Guidelines for Cybersecurity in Hospitals, 2020.
ENISA, Security Framework for Governmental, 2015.
ENISA, Threat Landscape Report 2018, 2019.
IBM, X-Force Threat Intelligence Index, 2020, pp. 39.
IT Governance Privacy Team, EU General Data Protection Regulation – An Implementation and

Compliance Guide, Third edition, It Governance Publishing, 2019.
Junaid Ahmad, B., Vinai, G., & Bilal, M., Cloud Computing with Machine Learning Could Help
Us in the Early Diagnosis of Breast Cancer, 2015 Second International Conference on
Advances in Computing and Communication Engineering, Dehradun, 2015, pp. 644-648,
doi: 10.1109/ICACCE.2015.62
Leng, S., Tan, R.S., Chai, K.T.C. et al., The electronic stethoscope, BioMed Eng OnLine, Vol.
14, No 66, 2015, https://doi.org/10.1186/s12938-015-0056-y
NIST, The NIST Definition of Cloud Computing, Information Technology Laboratory National
Institute of Standards and Technology, Gaithersburg, 2011.
NIST, NIST Cloud Computing Standards Roadmap, , Information Technology Laboratory

National Institute of Standards and Technology, 2013.
https://www.nist.gov/system/files/documents/itl/Cloud/NIST_SP-500-291_Version-
2_2013_June18_FINAL.pdf
OWASP, OWASP Mobile Top 10, 2016
40
January 2021
Sadhasivam, N., Balamurugan, R., and Pandi, M., Cancer Diagnosis Epigenomics Scientific
Workflow Scheduling in the Cloud Computing Environment Using an Improved PSO
Algorithm, Asian Pacific Journal of Cancer Prevention: APJCP, Vol. 19, No 1, 2018, pp. 243-
246, doi:10.22034/APJCP.2018.19.1.243
Security Week, A Deep Dive Into Hyperjacking, February 2011.
Vacca, J. R., Security in the private Cloud, Taylor & Francis Group LLC, Boca Raton, 2017.
Ventsislav, V. and Rosen, I., Cloud-Based System for Real Time Medication Monitoring. In
Proceedings of the 17th International Conference on Computer Systems and Technologies
2016 (CompSysTech '16), Association for Computing Machinery, New York , USA, 2016, pp.
151–158, doi : https://doi.org/10.1145/2983468.2983491
World Economic Forum, Understanding Systemic Cyber Risk, 2016, pp. 13.
41
January 2021
A ANNEX:
GENERAL PRACTICES
The tables presented below contain only the healthcare specific standards and guidelines. For a
complete cybersecurity standards overview, you can reference to the ENISA Procurement
Guide26 of 2020.
STANDARD
Name - Description Dimension (country)
ISA/IEC 62443 - A series of standards including technical reports to secure Industrial Automation Medical Devices (Health),
and Control Systems (IACS). Cybersecurity
NEN-7510 (NL) - This standard provides guidelines and principles for determining, setting and Cybersecurity
enforcing measures that an organisation in the healthcare sector must take to protect the (Netherlands)
information provision.
NEN-7512 - Health informatics - Information security in healthcare - Requirements for trusted Cybersecurity,
exchange of health information (NL) (Netherlands)
It applies to electronic communication in healthcare, between healthcare providers and healthcare
institutions and with patients and clients, healthcare insurers, and other parties involved in
healthcare.
NEN-7513 - Health informatics - Recording actions on electronic patient health records (NL) Cybersecurity
(Netherlands)
Hébergeurs de Données de Santé (HDS) - The Hébergeurs de Données de Santé (HDS) Cloud Security (France)
certification is required for entities such as Cloud service providers that host the personal health
data governed by French laws and collected for delivering preventive, diagnostic, and other health
services.
GUIDELINES AND FRAMEWORKS

Name Description Dimension (Country)
ANSSI SecNumCloud The ANSSI SecNumCloud is the French pendant to the Criteria Cloud Security
Catalogue C5, defining a baseline security level for Cloud computing. It
is used by professional Cloud service providers, auditors, and Cloud
customers. The criteria catalog was a collaboration work of Germany
and France.
Criteria Catalogue C5 – The Cloud computing compliance criteria catalog (C5) defines a baseline Cloud Security
Federal Office for security level for Cloud computing. It is used by professional Cloud
Information Security in service providers, auditors, and Cloud customers.
Germany (BSI)
Cloud Security Alliance The CSA Cloud control matrix is a framework to ensure information Cloud Security
(CSA) – Cloud Controls security for Cloud computing providing 133 controls structured along 16
Matrix domains covering all key aspects of Cloud technology. It can be used as
a tool to assess Cloud service providers and provides guidance.
Cybersecurity Maturity The CMMC is a certification and compliance process developed by the Cybersecurity
Model Certification Department of Defence. The certification aims at assessing the maturity
(CMMC) level of fulfilling information security standards and best practices.
26
https://www.enisa.europa.eu/publications/good-practices-for-the-security-of-healthcare-services
42
January 2021
Name Description Dimension (Country)
Health Information Trust HITRUST is a framework guiding the implementation of HIPPA Privacy / Cybersecurity
Alliance (HITRUST) requirements for healthcare providers. The HITRUST certification is a
way to show compliance with HIPPA requirements to third parties.
Principles and Practices The principles and practices for medical device of the international Cybersecurity Medical
for Medical Device medical device forum (IMDRF) cybersecurity have been designed to Devices
Cybersecurity27 provide concrete recommendations to all responsible stakeholders on
the general principles and best practices for medical device
cybersecurity.
Guías CCN-STIC de The CCN-STICH are instructions, guidelines, and recommendations of Cybersecurity (Spain)
Seguridad28 the Centro Criptológico Nacional, aiming at improving the maturity level
of the organisation’s information security.
CCN-STIC-823 The CCN-STICH-823 covers instructions, guidelines, and Cloud Security (Spain)
Seguridad en etornos recommendations of the Centro Criptológico Nacional, focusing on Cloud
Cloud29 services.
TRAFICOM guidelines The Finnish transport and communication agency and national Cybersecurity (Finland)
cybersecurity centre provide guidelines on information security.
Digital security: The Finnish Ministry of finance provides guidelines for information Cybersecurity (Finland)
Guidance of services security.
and security30
National Cybersecurity The Centro national de Cibersegurança provides a national Cybersecurity (Portugal)
Framework31 cybersecurity framework.
Security The Portuguese Ministry of health provides recommendations for Cybersecurity (Portugal)
Recommendations of ensuring cybersecurity.
Ministry of Health32
Official eHealth DSI The electronic health digital service infrastructure (eHDSI) describes a Cybersecurity
provider guidelines and solution to support implementing EU-wide projects for the healthcare
policies33 sector, focusing on cross-border healthcare data exchange. The digital
service infrastructure (DSI) supports interoperable services across the
EU.
27
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-pp-mdc-n60.pdf
28
https://www.ccn-cert.cni.es/guias.html
29
https://www.ccn-cert.cni.es/series-ccn-stic/800-guia-esquema-nacional-de-seguridad/541-ccn-stic-823-seguridad-en-
entornos-cloud.html
30
https://vm.fi/en/information-security-and-cybersecurity
31
https://www.cncs.gov.pt/en/
32
https://www.dgs.pt/directorate-general-of-health/structure-and-legal-framework.aspx
33
https://ec.europa.eu/cefdigital/wiki/display/EHOPERATIONS/eHDSI+STARTING+TOOLKIT
43
January 2021
B ANNEX:
MAPPING OF SECURITY
MEASURES
Natural Supply Malicious Human System

ID Name Measure phenomena Chain Action errors Failures
Failure
Identify security and data protection x x x x x

SM-01
requirements
Conduct a risk assessment and data x x x x x

SM-02
protection impact assessment
Establish processes for security and data

SM-03
protection incident management
Ensure business continuity and disaster x x x

SM-04
recovery
SM-05 Termination and secure data deletion x
SM-06 Auditing, logging and monitoring x x
Implement vulnerability and patch x x

SM-07
management
SM-08 Manage assets and classify information
Enable data encryption for data at rest x x

SM-09
and data in transit
SM-10 Ensure security of encryption keys x x
SM-11 Data portability and interoperability x
SM-12 Client and endpoint protection x x
SM-13 Authentication and access control x
Information security awareness, x

SM-14
education and training
SM-15 Network Security x x x
SM-16 Review isolation between tenants x
SM-17 Physical and environmental security x x x
44
XX-00-00-000-XX-X
ABOUT ENIS A
The European Union Agency for Cybersecurity, ENISA, is the Union’s agency dedicated to
achieving a high common level of cybersecurity across Europe. Established in 2004 and
strengthened by the EU Cybersecurity Act, the European Union Agency for Cybersecurity
contributes to EU cyber policy, enhances the trustworthiness of ICT products, services and
processes with cybersecurity certification schemes, cooperates with Member States and EU
bodies, and helps Europe prepare for the cyber challenges of tomorrow. Through
knowledge sharing, capacity building and awareness raising, the Agency works together
with its key stakeholders to strengthen trust in the connected economy, to boost resilience
of the Union’s infrastructure, and, ultimately, to keep Europe’s society and citizens digitally
secure. More information about ENISA and its work can be found at www.enisa.europa.eu.
ISBN: 978-92-9204-405-3
DOI: 10.2824/454966

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Belani Hrvoje, Croatia Ministry of Health, Croatia

Bezouška Tomáš, Ministry of Health of the Czech Republic, Czech Republic

Calcavecchia Franck, Hôpitaux Universitaires Genève, Switzerland

Callewaert Frank, Microsoft, Belgium

Carbonell Marta, Hospital Universitary Vall d'Hebron, Spain

Chondropoulos Konstantinos, General Hospital of Thessaloniki "George Papanikolaou", Greece

Drost René, NAMCO, Netherlands

Greenfield Søren Bank, Danish Health Data Authority, Denmark

Haro Albert, Cybersecurity Agency of Catalonia, Spain

Ikäheimonen Merja, Essote ky, Finland

Kirkmann Perit, Information System Authority, Estonia

Kokx Ben, Philips, Netherlands

Liebscher Thomas, Philips, Netherlands

Marek Dominik, Vysočina Region Regional Authority, Czech Republic

Meany Ben, Microsoft, Belgium

Pennings Florian, Microsoft, Belgium

Rad Abtin, TUEV SUED Product Service GmbH, Germany

Smethurst Chelsea, Microsoft, Belgium

Tzikas Athanasios, University Hospital of Larissa, Greece

Copyright for the image on the cover: © Shutterstock

ISBN 978-92-9204-405-3, DOI 10.2824/454966

ANSSI Agence Nationale de la Sécurité des Systèmes d'Information

API Application Programming Interface

AWS Amazon Web Services

BSI British Standards Institution

CCN Centro Criptológico Nacional

CDS Clinical Decision Support

CIO Chief Information Officer

CISO Chief Information Security Officer

CMMC Cybersecurity Maturity Model Certification

COVID Corona Virus Disease

CSA Cloud Security Alliance

CSP Cloud Security Provider

DSI Digital Service Infrastructure

EDPB European Data Protection Board

EDPS European Data Protection Supervisor

EFTA European Free Trade Association

EHR Electronic Health Record

ERP Enterprise Resource Planning systems

GDPR General Data Protection Regulation

HCO Health Care Organisation

HDS Hébergeurs de Données de Santé

HDSI Health Digital Service Infrastructure

HIPPA Health Insurance Portability and Accountability Act

HIS Health Information Systems

HITRUST Health Information Trust Alliance

IACS Industrial Automation and Control Systems

ICT Information and Communications Technology

IEC International Electrotechnical Commission

IMDRF International Medical Device Forum

JASEHN Joint Action to Support the eHealth Network

LIS Laboratory Information System

NISD Network and Information Security Directive

NIST National Institute of Standards and Technology