SoftwareCPR 2016 Standards Outlook

Sherman Eagles of SoftwareCPR expects increased standards and regulatory activity related to Software and HealthIT in 2016. Here are some of the areas to watch:

  • IEC 82304-1 Health Software: General requirements for safety will be completed during the first half of 2016. It is intended that this standard be harmonized in the EU, but it is not clear when this may happen.
  • A first committee draft of the second edition of IEC 62304 will be circulated for review in the first half of 2016. The second edition will expand the scope of the standard to health software.
  • New standards for health software covering all parts of the life cycle will be proposed in 2016.
  • AAMI will move its work on HIT quality management systems and HIT risk management forward. The goal is to complete these by the end of 2016.
  • A revision of IEC 80001-1 will begin in 2016.
  • The revision to ISO 13485 will be published in the first half of 2016.
  • ISO 14971 is currently under review. It is likely that a revision (amendment or new edition) will be started in 2016.
  • A second amendment to IEC 60601-1 will be started in the second half of 2016. This amendment is scheduled to be completed in 2019. A fourth edition of 60601-1 will be started following the completion of the amendment and will be scheduled for completion in 2024. Discussions about the structure of the fourth edition will likely begin in 2017 and decisions made before work is started on the fourth edition.
  • The first deliverables from UL/AAMI 2800 on medical device interoperability should be completed in 2016.
  • AAMI TIR 57 on medical device cybersecurity risk management will be published in 2016.
  • Many documents, both standards and regulations, on security and privacy will be in process during 2016.

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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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