Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

IEC/TR 80001-2-2:2012(E), which is a technical report, creates a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection. This security report presents an informative set of common, high-level security-related capabilities useful in understanding the user needs, the type of security controls to be considered and the risks that lead to the controls. Intended use and local factors determine which exact capabilities will be useful in the dialog about risk. The capability descriptions in this report are intended to supply health delivery organizations (HDOs), medical device manufacturers (MDMs), and IT vendors with a basis for discussing risk and their respective roles and responsibilities toward its management. This discussion among the risk partners serves as the basis for one or more responsibility agreements as specified in IEC 80001-1.

General Information

Status
Published
Publication Date
09-Jul-2012
Current Stage
PPUB - Publication issued
Start Date
30-Sep-2012
Completion Date
10-Jul-2012
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IEC TR 80001-2-2:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
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IEC/TR 80001-2-2
Edition 1.0 2012-07
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –

Part 2-2: Guidance for the disclosure and communication of medical device

security needs, risks and controls

IEC/TR 80001-2-2:2012(E)
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IEC/TR 80001-2-2
Edition 1.0 2012-07
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –

Part 2-2: Guidance for the disclosure and communication of medical device

security needs, risks and controls

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XA
ICS 11.040.01 ISBN 978-2-83220-202-9

– 2 – TR 80001-2-2  IEC:2012(E)
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 8
3 Terms and definitions . 8
4 Use of SECURITY CAPABILITIES . 12
4.1 Structure of a SECURITY CAPABILITY entry. 12
4.2 Guidance for use of SECURITY CAPABILITIES in the RISK MANAGEMENT PROCESS . 12
4.3 Relationship of ISO 14971-based RISK MANAGEMENT to IT security RISK
MANAGEMENT . 13
5 SECURITY CAPABILITIES . 14
5.1 Automatic logoff – ALOF . 14
5.2 Audit controls – AUDT . 14
5.3 Authorization – AUTH . 15
5.4 Configuration of security features – CNFS . 16
5.5 Cyber security product upgrades – CSUP . 16
5.6 HEALTH DATA de-identification – DIDT . 17
5.7 Data backup and disaster recovery – DTBK . 17
5.8 Emergency access – EMRG . 17
5.9 HEALTH DATA integrity and authenticity – IGAU . 18
5.10 Malware detection/protection – MLDP . 18
5.11 Node authentication – NAUT . 18
5.12 `Person authentication – PAUT . 19
5.13 Physical locks on device – PLOK . 19
5.14 Third-party components in product lifecycle roadmaps – RDMP . 20
5.15 System and application hardening – SAHD . 20
5.16 Security guides – SGUD . 21
5.17 HEALTH DATA storage confidentiality – STCF . 21
5.18 Transmission confidentiality – TXCF. 22
5.19 Transmission integrity – TXIG . 22
6 Example of detailed specification under SECURITY CAPABILITY: Person
authentication – PAUT . 22
7 References . 23
8 Other resources . 25
8.1 General . 25
8.2 Manufacture disclosure statement for medical device security (MDS2) . 25
8.3 Application security questionnaire (ASQ) . 25
8.4 The Certification Commission for Healthcare Information Technology
(CCHIT). 25
8.5 http://www.cchit.org/get_certifiedHL7 Functional Electronic Health Record
(EHR) . 26
8.6 Common criteria – ISO/IEC 15408 . 26
9 Standards and frameworks . 26
Annex A (informative) Sample scenario showing the exchange of security information . 27
Annex B (informative) Examples of regional specification on a few SECURITY
CAPABILITIES . 48

TR 80001-2-2  IEC:2012(E) – 3 –
Annex C (informative) SECURITY CAPABILITY mapping to C-I-A-A . 52
Bibliography . 53

Table 1 – Relationship of IT security and ISO 14971-based terminology . 13
Table C.1 – Sample mapping by a hypothetical HDO . 52

– 4 – TR 80001-2-2  IEC:2012(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR
IT-NETWORKS INCORPORATING MEDICAL DEVICES –

Part 2-2: Guidance for the disclosure and communication of medical
device security needs, risks and controls

FOREWORD
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The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 80001-2-2, which is a technical report, has been prepared a Joint Working Group of
subcommittee 62A: Common aspects of electrical equipment used in medical practice, of
IEC technical committee 62: Electrical equipment in medical practice and ISO technical
committee 215: Health informatics.

TR 80001-2-2  IEC:2012(E) – 5 –
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/783/DTR 62A/807/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
Terms used throughout this technical report that have been defined in Clause 3 appear in
SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – TR 80001-2-2  IEC:2012(E)
INTRODUCTION
IEC 80001-1, which deals with the application of RISK MANAGEMENT to IT-networks
incorporating medical devices, provides the roles, responsibilities and activities necessary for
RISK MANAGEMENT. This technical report provides additional guidance in how SECUR
...

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