ISO/TS 23535:2022

TECHNICAL ISO/TS
SPECIFICATION 23535
First edition
2022-01
Health informatics — Requirements
for customer-oriented health cloud
service agreements
Reference number
© ISO 2022
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ii
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Cloud computing in health and healthcare . 4
4.1 Cloud computing in hospital . 4
4.2 Gap between CSC’s expectation and CSP’s solution . 4
5 CSA for health and healthcare . 5
5.1 Roles and responsibilities . 5
5.1.1 Cloud service customer . 5
5.1.2 Cloud service provider . 7
5.2 Service support .12
5.2.1 Service catalogue .12
5.2.2 Service coverage . 13
5.2.3 Uninterrupted service . 13
5.2.4 Accountability for service interruption . 13
5.2.5 Compensation for service interruption . 13
5.2.6 Service downtime . 13
5.2.7 Service disruption notification . 13
5.2.8 Target response time . 14
5.2.9 Information on subcontractors . 14
5.3 Service model. 14
5.4 Service monitoring . 14
5.5 Incident reporting. 15
5.5.1 Incident report . 15
5.5.2 Incident response . 15
5.5.3 Incident report delivery . 15
5.5.4 Repair time .15
5.6 Standards, testing, and certification . 15
5.6.1 Conformity with international standards . 15
5.6.2 Guidelines for ensuring compatibility between clouds . 15
5.6.3 Support data input . 16
5.6.4 Adopt international standards . 16
5.6.5 Compliance with non-international standards . 16
5.6.6 Compliance test . 16
5.6.7 Compliance with updated standards . 16
5.6.8 Certification details . 16
5.7 Data location . 16
5.7.1 Cloud service area and location . 16
5.7.2 Cloud relocation . 16
5.7.3 Violation of advance notice . 16
5.8 Data governance . 16
5.8.1 Cloud data maintenance policy . 16
5.8.2 Cloud data backup plan . 17
5.8.3 Cloud data collection . 17
5.8.4 Cloud data query history . 17
5.9 Data security . 17
5.9.1 Technical security measures . 17
5.9.2 Administrative security measures . 17
5.9.3 Physical security measures . 18
5.9.4 Simulation for technical security measures . 18
iii
5.9.5 Data integrity assurance . 18
5.9.6 De-identification . 18
5.10 Data transfer . 18
5.10.1 Data transfer deadline. 18
5.10.2 Data transfer method . 18
5.10.3 Data transfer roles . 18
5.10.4 Data deletion method . 18
5.10.5 Data transfer customer approval . 18
5.10.6 Approved data transfer range . 18
5.10.7 Responsibilities for data transfer violation . 19
5.11 Billing system and operation policies . 19
5.11.1 Billing system criteria . 19
5.11.2 Internal cloud operational policy . 19
5.11.3 Billing for excess usage . 19
5.12 Payments . 19
5.12.1 Payment method/time . 19
5.12.2 Payment period . 19
5.12.3 Payment method. 19
5.12.4 Explanation of billing details . 19
5.13 Regulatory compliance . 19
5.13.1 Jurisdiction compliance . 19
5.14 Service update and version management . 20
5.14.1 Service update notification . 20
5.14.2 Change notification upon service update . 20
5.14.3 Service update stability assessment . . 20
5.14.4 Service version management . 20
5.15 Agreement renewal and expiry .20
Annex A (informative) Summary of security and privacy and metric model components .21
Annex B (informative) Service catalogues and cost estimate .23
Bibliography .26
iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
Introduction
Healthcare services go beyond the boundaries of physical providers, such as clinics or hospitals. Cloud
computing, cognitive computing, virtual reality/augmented reality, IoT, robot and wearable devices
have contributed to enhanced accessibility and provide value to customer health, addressing customer
demand for tailored healthcare services. Modern ICT is the catalyst to the promotion of customer
engagement and empowerment, especially through cloud-based services.
Cloud computing offers shared and configurable collections of computing resources and services that,
typically over the Internet, are made available with minimal management effort. It eliminates the
distinction between the physical and virtual resources by providing access from various devices such
as wearable, wellness devices and mobile phones. There are six key characteristics of cloud computing:
— broad network access,
— measured service,
— multi-tenancy,
— on-demand self-service,
— rapid elasticity and scalability, and
— resource pooling;
and three service models:
— Software as a Service(SaaS),
— Platform as a Service (PaaS), and
— Infrastructure as a Service (IaaS).
Cloud computing is expected to bring substantial and practical impact to healthcare services from a
customer perspective. Customers may enjoy by a contract customer-centric health services from the
cloud provider. The cloud provider offers a variety of benefits to its customers, such as predictive
disease analytics and evidence-based management of chronic diseases.
Health cloud services have evolved into a knowledge platform on which customer health data, including
generic data, are collected through multi-model data collection channels, and are made accessible
anywhere by any device or application. These data are analysed by sophisticated analytical techniques
such as artificial intelligence and inform personalized health-related advice and insights.
Health cloud services deal with critical and sensitive information related to life and health and are
subjected to regulations such as HIPPA and GDPR. The quality and quantity of services vary, depending
upon operating environments, supported devices, available intelligent analysis capacities, and service
level agreements. Regardless of the duration of a service contract with the health cloud provider, it is
important to establish standards for a minimum set of cloud service functions that ensures customer
protection.
When a customer holds contracts with multiple health cloud service providers, it is important to ensure
consistency of shared data between the providers. A clear demarcation of liability may be hard to
obtain in a disastrous event when the customer subscribes to various cloud service models. In case
of migrating from one service provider to another, there should be a method to validate the migration
is carried out in compliance with health-industry-specific criteria (e.g., rules on customer health data
transfer or deletion).
Healthcare is under transformation - manifested by the departure from the traditional face-to-face
healthcare services between stakeholders, such as hospitals, caregivers, and patients. In addition,
the general acceptance of customer empowerment is enabled by widespread dissemination of web
technology and cloud computing, creating various healthcare services such as virtual hospitals,
vi
telehealth, online visit, and mobile health management. Health cloud services offer computer-customer
interviewing, home telehealth, and health monitoring through wearable/wellness devices.
The purpose of this document is to classify key characteristics of a cloud service agreement from the
perspectives and interest of the customer and to provide an agreement list pivotal to the provision of
customer-oriented healthcare service.
Please note that any trade name used in this document is information given for the convenience of users
and does not constitute an endorsement.
vii
TECHNICAL SPECIFICATION ISO/TS 23535:2022(E)
Health informatics — Requirements for customer-oriented
health cloud service agreements
1 Scope
This document describes a core set of cloud service agreements for customer-oriented health cloud
services.
This document covers a customer-oriented cloud service agreement that can be used in healthcare
organizations and public health centers that use health cloud services.
This document defines key characteristics in the health cloud service agreement that are indispensable
in providing optimal health/healthcare management functionalities. Privacy and security features are
considered outside the scope of this document and are covered in ISO/TR 21332.
The purpose of this document is to present matters to be considered (e.g., cloud type, components, key
characteristics) by stakeholders involved in the implementation of cloud computing in hospitals or
healthcare organizations. The potential users of this document are mainly 1) IT managers of hospitals,
2) hospital management, and 3) cloud service providers and cloud partners that provide services to
healthcare institutions.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
application capabilities type
cloud capabilities type (3.2) in which the cloud service customer (3.9) can use the cloud service provider’s
(3.10) applications
[SOURCE: ISO/IEC 17788:2014, 3.2.1]
3.2
cloud capabilities type
classification of the functionality provided by a cloud service (3.5) to the cloud service customer (3.9)
based on resources used
[SOURCE: ISO/IEC 17788:2014, 3.2.4]
3.3
customer-oriented
relating to the needs and interests of individual customers, including businesses
3.4
cloud computing
paradigm for enabling network access to a scalable and elastic pool of shareable physical or virtual
resources with self-service provisioning and administration on-demand
[SOURCE: ISO/IEC 17788:2014, 3.2.5]
3.5
cloud service
one or more capabilities offered via cloud computing (3.4) involved using a defined interface
[SOURCE: ISO/IEC 17788:2014, 3.2.8]
3.6
cloud service agreement
CSA
documented agreement between the cloud service provider (3.10) and cloud service customer (3.9) that
governs the covered service(s)
[SOURCE: ISO/IEC 22123-1:2021, 3.8.8, modified – Note to entry removed.]
3.7
cloud service category
group of cloud services (3.5) that possess some common set of qualities
[SOURCE: ISO/IEC 17788:2014, 3.2.10, modified – Note to entry removed.]
3.8
cloud service characteristic
qualitative or quantitative property of a cloud service (3.5)
[SOURCE: ISO/IEC 19086-2:2018, 3.1]
3.9
cloud service customer
CSC
party (3.16) which is in a business relationship for the purpose of using cloud services (3.5)
[SOURCE: ISO/IEC 17788:2014, 3.2.11]
3.10
cloud service provider
CSP
party (3.16) which makes cloud services (3.5) available
[SOURCE: ISO/IEC 17788:2014. 3.2.15]
3.11
incident conclusion report
final report on failures submitted to the provider, organized and prepared in chronological order,
specified by explanations and countermeasures
3.12
infrastructure as a service
IaaS
cloud computing (3.4) service model defined in section 2 of the NIST Definition of Cloud Computing
[SP800145]
[SOURCE: ISO/IEC 19831:2015, 3.8]
3.13
measurement
set of operations having the objective of determining a measurement result (3.14)
[SOURCE: ISO/IEC 19086-2:2018, 3.4]
3.14
measurement result
value that expresses a qualitative or quantitative assessment of a cloud service characteristic (3.8)
[SOURCE: ISO/IEC 19086-2:2018, 3.5]
3.15
metric
standard of measurement that defines the conditions and the rules for performing the measurement
(3.13) and for understanding the measurement result (3.14)
[SOURCE: ISO/IEC 19086-2:2018, 3.6, modified – Note to entry removed.]
3.16
party
natural person or legal person, whether or not incorporated, or a group of either
[SOURCE: ISO 27729:2012, 3.1]
3.17
software as a service
SaaS
cloud service category (3.7) in which the cloud capabilities type (3.2) provided to the cloud service
customer (3.9) is an application capabilities type (3.1)
[SOURCE: ISO/IEC 17788:2014, 3.2.36]
3.18
target response time
maximum wait time for a response to a request
3.19
platform as a service
PaaS
cloud service category (3.7) in which the cloud capabilities type (3.2) provided to the cloud service
customer (3.9) is a platform capabilities type (3.20)
[SOURCE: ISO/IEC 17788:2014, 3.2.30]
3.20
platform capabilities type
cloud capabilities type (3.2) in which the cloud service customer (3.9) can deploy, manage, and run
customer-created or customer-acquired applications using one or more programming languages and
one or more execution environments supported by the cloud service provider (3.10)
[SOURCE: ISO/IEC 17788:2014, 3.2.31]
3.21
interoperability
ability of two or more systems or applications to exchange information and to mutually use the
information that has been exchanged
[SOURCE: ISO/IEC 17788:2014, 3.1.5]
3.22
service level agreement
SLA
documented agreement between the service provider and customer that identifies services and service
targets
[SOURCE: ISO/IEC 17788:2014, 3.1.7, modified – Note to entry removed.]
4 Cloud computing in health and healthcare
4.1 Cloud computing in hospital
Cloud computing has been adopted in many domains. Hospital IT experts are seeking cloud services
that correspond with characteristics of hospital operation. Health cloud providers should deliver
services that match the demands particular to the health/healthcare industry. Hospital IT systems
perform complex functions that protect patient safety and provide timely data required by healthcare
practitioners. Because such systems normally operate non-stop, system stability is a critical factor.
Due to the integration of various devices and hospital information systems, system sustainability is
important. Healthcare service is disrupted in the event of a system breakdown. It is thus important to
have stable systems as they have a direct impact on all connected equipment and devices.
4.2 Gap between CSC’s expectation and CSP’s solution
An important factor to consider is predictability and preciseness of the services provided by the
cloud service provider. There is likely to be a gap between the expectations of a hospital as a cloud
service customer and the solution offered by a cloud service provider. First, the gap can originate
from the difficulty in specifying detailed requirements/characteristics from the customer to the
cloud service provider or operator. Second, it can also come from the highly abstract characteristics
of cloud computing, which makes it difficult to translate into functional units. And third, the range of
responsibilities to be defined when implementing health cloud services can easily be unclear due to the
lack of common criteria between cloud service customers and providers.
As-Is To-Be
Figure 1 — Expected role of a health cloud service agreement
These factors make it difficult to construct and put in action the measures in the event of accidents
(incident recovery scenario). A list of agreements, as detailed as possible, is required to eliminate the
ambiguity of the range of responsibilities. Fourth, services provided by multiple providers are not easy
to compare or evaluate one against another while applying the same criteria. Fifth, it is difficult to
ascertain all the facts of those services available in the real-world environment. Sixth, service contacts
are not time-bound; service termination and renewal with new service details can happen over
time, creating complex problems such as data security and migration. Overall, the key to successful
implementation of health cloud services lies in the establishment of clear criteria between hospitals
and cloud service providers (Figure 1).
A CSA defines basic common agreement requirements from the customer’s perspective. Conceptual-
level agreements are specified in detail to enhance understanding of service functions. General criteria
of health cloud services are presented so that the customer can use the CSA in comparing and evaluating
services from various providers. A detailed description of the CSA is expected to clarify the range of
duties and responsibilities of the provider and the customer. The CSA is applicable to various cloud
service models, such as SaaS. This document specifies general requirements, regardless of the service
models in view. An example factors in a CSA to be considered are shown in Figure 2.
Figure 2 — CSA factors
5 CSA for health and healthcare
5.1 Roles and responsibilities
5.1.1 Cloud service customer
5.1.1.1 General
Service customers are parties that are in a business relationship for the purpose of using the cloud.
They are cloud service users, cloud service administrators, and cloud service business managers.
5.1.1.2 Cloud service user
A cloud service user engages in various activities that include the services provided by the cloud service
provider. The user credentials are authenticated by the cloud service provider and the user is granted
access to the cloud service.
5.1.1.3 Cloud service administrator
A cloud service administrator is responsible for overseeing the operation of the customer's use of the
cloud services and all operational processes associated with the customer's existing ICT systems. To
ensure effective administration of the services, the cloud service administrator can engage in the
following, but not limited to, activities:
a) Trial execution of the service: the cloud service provider's service may be used as a trial to check its
suitability for the business needs of the customer. The trial is initiated with mutual agreement and
understanding between the cloud service provider and the customer.
1) The cloud service administrator may collect user credentials to the cloud service provider for
trial services.
2) The service is tested to see if it fits the business requirements.
b) Service monitoring: the cloud service administrator monitors the performance of the service
1) The cloud service administrator tracks service usage to ensure that it is properly used.
2) The cloud service administrator ensures that the integration of the existing ICT systems and
the cloud service is achieved in a way that the business goals are met.
3) The cloud service administrator checks the measurements and performance indicators related
to the service (e.g., service availability, frequency of service interruptions, average help desk
repair time).
4) The cloud service administrator monitors performance indicators such as data usage.
5) The cloud service administrator evaluates the provided service quality against the agreed
service quality.
c) Security management:
1) It is necessary to manage an appropriate security environment for cloud service customer
data.
2) Data backup and recovery, replication and failover plans may be established.
3) Security policies are to be in place and evaluated.
4) Encryption and integrity methods for service customer data may be employed and evaluated.
d) Billing and usage report:
1) The cloud service administrator makes reports on the use of cloud services.
2) The cloud service administrator makes reports on billing/invoice data related to usage.
e) Incident report processing: the cloud service administrator reports on customer-related problems.
1) The cloud service administrator evaluates the impact of each incident.
2) The cloud service administrator identifies the cause of the incident.
3) The cloud service administrator checks the incident report prepared by the cloud service
provider.
4) The cloud service administrator develops alternatives to solving the incident.
5) The cloud service administrator identifies issues that may not have been resolved within an
agreed-upon time frame or have a significant business impact.
f) Tenancy management: the cloud service administrator manages tenancy agreed-upon between the
service customer and the cloud service provider. The tenancy agreement may include:
1) User accounts, security roles, identities, and privileges.
2) Steps to identify and control data shared among tenancy users.
3) Tenant creation and removal, and allocated resources.
4) Enforcement policies for each tenant.
5.1.1.4 Cloud service business manager
A cloud service business manager is responsible for managing the business in an efficient manner
to achieve the business goals of the customer. The cloud service business manager can engage in the
following, but not limited to, activities:
a) Accounting and finance: the cloud service business manager deals with accounting and financial
aspects in relation to the cloud service.
1) The cloud service business manager aligns the business plans with the cloud services.
2) The cloud service business manager manages accounting and financial details in relation to
cloud service usage.
3) The cloud service business manager processes the billing/invoices received from the cloud
service provider and makes sure that the bills are commensurate with the usage data.
4) The cloud service business manager manages cloud service customers.
5) The cloud service business manager manages payments to the cloud service provider.
6) The cloud service business manager maintains the cloud account.
b) Service selection and purchase:
1) The cloud service business manager investigates the service offerings from cloud service
providers to determine the service that corresponds with the business and technical
requirements of the customer.
2) The cloud service business manager analyses services and related prices in the SLA.
3) The cloud service business manager negotiates terms of agreement for cloud services.
4) The cloud service business manager manages cloud service contracts and registration.
c) Audit report request: the cloud service business manager prepares reports on cloud audit requested
by the customer in compliance with audit standards or systems.
5.1.2 Cloud service provider
5.1.2.1 Cloud service provider
A cloud service provider is responsible for providing cloud services and performing necessary activities
for service maintenance. Cloud service providers include cloud service operation managers, cloud
service deployment managers, cloud service managers, cloud service business managers, customer
support and care representatives, inter-cloud providers, cloud service security and risk managers, and
network providers.
5.1.2.2 Cloud service operations manager
A cloud service operations manager is responsible for operational processes and procedures and
manages services and related infrastructure in accordance with operational goals.
a) System preparation:
1) The cloud service operations manager evaluates the impact of deploying new services or
expanding the use of existing services.
2) The cloud service operations manager manages the capacities of data center resources to meet
the needs of new deployments.
b) Service monitoring and management:
1) The cloud service operations manager monitors services and infrastructure of the supplier.
2) The cloud service operations manager identifies and maintains events and related data of
importance to the supplier's business.
3) The cloud service operations manager manages network infrastructure, including routers,
domain name servers, IP addresses, and virtual individuals.
4) The cloud service operations manager supervises storage allocation.
5) The cloud service operations manager manages authentication and authorization of users.
6) The cloud service operations manager configures and maintains operating systems and
hypervisors.
7) The cloud service operations manager manages virtualization environments.
8) The cloud service operations manager ensures safe operation of the ICT environment of the
supplier and that SLAs are met.
c) Asset and inventory management:
1) The cloud service operation manager supervises computing, storage, network, and software
assets and their relationships.
2) The cloud service operations manager oversees versions, patch levels, and configuration
information.
3) The cloud service operations manager administers new assets and safely dispose of old assets.
d) Provision of audit data: The cloud service operations manager provides audit related data according
to audit plans or standards.
5.1.2.3 Cloud service deployment manager
A cloud service deployment manager activates the operational processes and execute services in the
early stages of service deployment.
a) Environment and process definition: the cloud service deployment manager governs the technical
environment and operation for the processes employed in service deployment.
1) The cloud service deployment manager manages software dependencies including technical
environment configuration such as storage and network resources.
2) The cloud service deployment manager governs changes in usage requirements in policies that
affect resource expansion or reduction.
3) The cloud service deployment manager ensures compliance with appropriate standards for
security and business.
4) The cloud service deployment manager defines the processes related to service execution and
modification, service upgrade and plans.
b) Metric definition and collection: recommended components in a metric model are set forth in
ISO/IEC TR 23951:2020, Annex A.2.
1) The cloud service deployment manager defines metrics used in SLAs.
2) The cloud service deployment manager develops methods for capturing metrics for each cloud
service.
3) The cloud service deployment manager defines metric reporting and management methods so
that SLA targets are met.
c) Deployment stage definition: the cloud service deployment manager defines service deployment
stages.
5.1.2.4 Cloud service manager
A cloud service manager may ensure that the service is functioning correctly for use by the customer
and that the service meets the goals specified in the SLA. The cloud service manager shall ensure stable
operation of the supplier's business support systems and operation support systems and be responsible
for the operation of functions provided to customers and partners.
a) Service provision: The cloud service manager may govern overall cloud services offered to the
customer, including receipt and processing of service calls from customers. The cloud service
manager authorizes and authenticates user identities and may be able to execute configuration and
invocation of other services. The activities of the cloud service manager in this regard includes the
following, but not limited to, activities:
1) The cloud service manager handles processes that deal with service defects.
2) The cloud service manager manages business support systems and operation support systems.
3) The cloud service manager manages the services and infrastructure offered to the customer.
4) The cloud service manager manages system process automation.
5) The cloud service manager supervises long-term capacity maintenance and performance
trends.
6) The cloud service manager manages computing and storage requirements for maintenance
updates on hardware.
7) The cloud service manager manages network functions for the data centers.
8) The cloud service manager oversees resources required to run the data centers and provide
support.
b) Service arrangement and provision:
1) The cloud service manager performs network endpoint activities that the customer can access
and that handle service requests of the customer.
2) The cloud service manager follows distribution processes defined for the service.
c) Service level management: the cloud service manager manages SLA target compliance. The cloud
service manager monitors metrics for each service and compare them with service targets. When a
metric does not meet the value required by the SLA, actions may be taken to re-deliver and deploy
the service. If compliance cannot be maintained, report the issue to the relevant stakeholders.
5.1.2.5 Cloud service business manager
A cloud service business manager tracks customers' business plans, define service delivery strategies,
and manage business relationships.
a) Business plans:
1) The cloud service business manager defines service offerings that include technical details and
SLAs.
2) The cloud service business manager develops business plans for services offered to customers.
3) The cloud service business manager oversees the financial and technical aspects of the service,
defines target audiences, develops, and maintains contracts and SLAs, and handles channel
markets and sales targets.
4) The cloud service business manager endeavours to achieve planned financial goals of the cloud
provider, using such means as tracking sales and boosting service usage.
b) Customer relationship management: the cloud service business manager oversees business
relationship with customers.
1) The cloud service business manager develops and maintain product catalogues (examples of
product catalogues are set forth in B.1).
2) The cloud service business manager provides a point of contact for the customers.
3) The cloud service business manager resolves concerns or issues raised by the customers.
c) Financial management:
1) The cloud service business mana
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