IEC/DTS 81001-2-2
(Main)Health software and health IT systems safety, effectiveness and security — Part 2-2: Guidance for the implementation, disclosure and communication of security needs, risks and controls
Health software and health IT systems safety, effectiveness and security — Part 2-2: Guidance for the implementation, disclosure and communication of security needs, risks and controls
This document presents an informative set of common, high-level security-related capabilities and additional considerations to be used across the entire life cycle of HEALTH SOFTWARE (including MEDICAL DEVICE software) and for the information exchange between the MEDICAL DEVICE MANUFACTURERS (MDMs), health software manufacturers, HEALTH DELIVERY ORGANIZATIONS (HDOs) and/or other stakeholders.
Sécurité, efficacité et sûreté des logiciels de santé et des systèmes TI de santé — Partie 2-2: Recommandations pour la mise en œuvre, la divulgation et la communication des besoins, des risques et des contrôles en matière de sécurité
General Information
Relations
Standards Content (Sample)
FINAL DRAFT
Technical
Specification
ISO/TC 215
Health software and health IT
Secretariat: ANSI
systems safety, effectiveness and
Voting begins on:
security —
2025-06-13
Part 2-2:
Voting terminates on:
2025-08-08
Guidance for the implementation,
disclosure and communication of
security needs, risks and controls
Sécurité, efficacité et sûreté des logiciels de santé et des systèmes
TI de santé —
Partie 2-2: Recommandations pour la mise en œuvre, la
divulgation et la communication des besoins, des risques et des
contrôles en matière de sécurité
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPORTING D OCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
This draft is submitted to a parallel vote in ISO and in IEC.
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAND ARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
© ISO 2025
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© IEC 2025 – All rights reserved
ii
IEC DTS 81001-2-2 © IEC 2025
1 CONTENTS
3 FOREWORD . 3
4 INTRODUCTION . 5
5 1 Scope . 7
6 2 Normative references . 7
7 3 Terms and definitions . 8
8 4 Use of security capabilities . 9
9 4.1 Structure of a security capability entry . 9
10 4.2 Guidance on the communication of security capabilities and shared
11 responsibility . 9
12 4.3 Guidance for use of security capabilities in the risk management process . 9
13 4.4 Guidance on the application of risk management processes . 9
14 5 Security capabilities . 10
15 5.1 General . 10
16 5.2 Automatic logoff (ALOF) . 11
17 5.3 Audit controls (AUDT) . 12
18 5.4 Authorization (AUTH) . 13
19 5.5 Cybersecurity product upgrades (CSUP) . 14
20 5.6 Health data de-identification (DIDT) . 15
21 5.7 Data backup and disaster recovery (DTBK) . 16
22 5.8 Emergency access (EMRG) . 16
23 5.9 Health data integrity and authenticity (IGAU) . 17
24 5.10 Malware detection/protection (MLDP). 17
25 5.11 Node authentication (NAUT) . 18
26 5.12 Person authentication (PAUT) . 19
27 5.13 Physical locks on product (PLOK) . 20
28 5.14 Third-party components in product life cycle roadmaps (RDMP) . 20
29 5.15 System and application hardening (SAHD) . 21
30 5.16 Health data storage confidentiality (STCF) . 21
31 5.17 Transmission confidentiality (TXCF) . 22
32 5.18 Transmission integrity and authenticity (TXIG) . 22
33 6 Additional supporting information . 22
34 6.1 General . 22
35 6.2 Connectivity capabilities (CONN) . 23
36 6.3 Management of personally identifiable information (MPII) . 23
37 6.4 Remote services (RMOT) . 24
38 6.5 Software Bill of Materials (SBOM) . 25
39 6.6 Security guides (SGUD) . 26
40 7 Examples of some security capabilities . 26
41 7.1 Example of detailed specification under security capability: Person
42 authentication (PAUT) . 26
43 7.2 Example for Software Bill of Materials (SBOM) . 27
44 8 References and other resources . 28
45 8.1 General . 28
46 8.2 Manufacturer disclosure statement for medical device security (MDS2) . 29
47 8.3 Application security questionnaire (ASQ) . 29
IEC DTS 81001-2-2 © IEC 2025
48 8.4 HL7 Functional Electronic Health Record (EHR) . 29
49 8.5 Standards and frameworks. 29
50 Annex A (informative) Sample scenario showing the exchange of security information . 32
51 A.1 Introduction to the security characteristics scenario . 32
52 A.2 Manufacturer Disclosure Statement for Medical device Security (MDS2) . 33
53 Annex B (informative) Examples of regional specification on a few security capabilities . 47
54 Annex C (informative) Guidance for selecting security controls to satisfy the security
55 capabilities . 50
56 C.1 General . 50
57 C.2 Automatic logoff (ALOF) . 53
58 C.3 Audit controls (AUDT) . 54
59 C.4 Authorization (AUTH) . 56
60 C.5 Cybersecurity product upgrades (CSUP) . 59
61 C.6 Health data de-identification (DIDT) . 60
62 C.7 Data backup and disaster recovery (DTBK) . 62
63 C.8 Emergency access (EMRG) . 64
64 C.9 Health data integrity and authenticity (IGAU) . 65
65 C.10 Malware detection/protection (MLDP). 67
66 C.11 Node authentication (NAUT) . 70
67 C.12 Person authentication (PAUT) . 72
68 C.13 Physical locks on product (PLOK) . 75
69 C.14 Third-party components in product life cycle roadmaps (RDMP) . 77
70 C.15 System and application hardening (SAHD) . 79
71 C.16 Health data storage confidentiality (STCF) . 83
72 C.17 Transmission confidentiality (TXCF) . 85
73 C.18 Transmission integrity and authenticity (TXIG) . 87
74 C.19 Connectivity capabilities (CONN) . 88
75 C.20 Management of personally identifiable information (MPII) . 90
76 C.21 Remote services (RMOT) . 91
77 C.22 Software Bill of Materials (SBOM) . 92
78 C.23 Security guides (SGUD) . 94
79 Annex D (informative) Security capability and additional security information mapping
80 to C-I-A-A-A . 98
81 Bibliography . 100
82 Alphabetized index of defined terms . 104
84 Figure 1 – Health software Field of Application as shown in IEC 81001-5-1 [2] . 7
85 Figure 2 – Sample Structure for “Medical device2” . 27
87 Table 1 – Example SBOM for “Medical device2” . 28
88 Table D.1 – Sample mapping by a hypothetical HDO . 98
IEC DTS 81001-2-2 © IEC 2025
91 INTERNATIONAL ELECTROTECHNICAL COMMISSION
92 ____________
94 HEALTH SOFTWARE AND HEALTH IT SYSTEMS SAFETY,
95 EFFECTIVENESS AND SECURITY –
97 Part 2-2: Coordination – Guidance for the implementation, disclosure and
98 communication of security needs, risks and controls
100 FOREWORD
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