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SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, our report keeps you up to date on new standards activity and gives you expert insight into future changes to existing standards.
Standards Outlook for 2022
Standards Published in 2021
The standard recently published that will likely become used by regulators to establish best practices for cybersecurity is IEC 81001-5-1.
Edition 2.0 (2021-09-21)
Application of risk management for IT-networks incorporating medical devices – Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Edition 1.0 (2021-03-31)
Health software and health IT systems safety, effectiveness and security – Part 1: Principles and concepts
Edition 1.0 (2021-12-16)
Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle
Edition 1.0 (2021-07-30)
Health software – Part 2: Health and wellness apps – Quality and reliability
Standards Currently In Development
None of the documents in development or proposed for new work in IEC or ISO are expected to be completed in 2022.
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
Application of risk management for IT-networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
Health software and health IT systems safety, effectiveness, and security – Part 2-1: Coordination – Guidance for the use of assurance cases for safety and security
AAMI documents in development
These are expected to be completed in 2022. Current drafts of these documents are being balloted in AAMI.
ANSI/AAMI SW96 (new)
Standard for medical device security — Security risk management for device manufacturers
AAMI TIR45 (revised)
Guidance on the use of AGILE practices in the development of medical device software
Items Proposed but not yet begun
Preliminary work is underway on these and they are likely to be approved for more formal activity during 2022.
IEC TR 62366-2:2016 Edition 2
Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
ISO 34971
Application of 14971 to Artificial Intelligence for Risk Management
Artificial Intelligence/Machine Learning-enabled Medical Device – Performance Evaluation Process
Testing of Artificial Intelligence / Machine Learning-enabled Medical Devices
A new Ad Hoc Group (AHG)
Safe, Effective and Secure Digital Therapeutics is being established by ISO TC 215 and IEC SC 62A.
The AHG is to:
(a) provide recommendations on how to integrate digital therapeutics into the shared scopes of TC 215 and IEC/SC 62A
(b) provide a report on Safety, Effectiveness and Security of Digital Therapeutics, including an initial list of potential new work item proposals and revisions to existing standards