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safety
FDA, together with the National Science Foundation (NSF) and the Department of Homeland Security Science, and Technology, held a public workshop May 18-19, 2017. Results of this workshop, including webcasts of the sessions, are at the FDA website. Public Workshop – Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis, May 18-19, 2017
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http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm525916.htm
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Sherman Eagles of SoftwareCPR® recently coauthored an article published by AAMI in the Jan/Feb 2016 BIT Journal entitled “Cybersecurity for Medical Device Manufacturers: Ensuring Safety and Functionality.”  You can read the article at this link: 2016 Jan-Feb BIT Cybersecurity Sherman is well known as an expert in medical device standards and has been involved in many...
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NOTE: This is for historical reference as a final guidance was issued Sept 2017 and is posted separately. FDA issued a new draft guidance entitled “Design Considerations and Pre- market Submission Recommendations for Interoperable Medical Devices”. This guidance addresses medical devices that exchange information whether wired or wireless including through the internet. It includes unidirectional...
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Note:  This draft is OBSOLETE and included only for historical reference only.  Look for the final draft elsewhere on this site. To view the guidance click this link:  2016-01-FDA Post market Cybersecurity draft guidance This guidance references a number of Presidential Executive Orders related to critical infrastructure and cybersecurity as a driving force for FDA’s increased oversight...
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Interesting write up: “How Medical Tech Gave a Patient a Massive Overdose”.  The article can be found at https://www.healthleadersmedia.com/innovation/how-medical-tech-gave-patient-massive-overdose
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http://www.ecri.org/press/Pages/Alarms-Health-IT-Patient-Violence-2015-Top-10-Patient-Safety-Concerns.aspx
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The Joint Commission, the nation’s largest accreditation organization for hospitals offers a free one hour online course entitled “Investigating and Preventing Health Information Technology-Related Patient Safety Events” at the link provided. https://www.jointcommission.org/topics/free_online_education_courses.aspx
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HIT Implementation, Usability and Safety Workgroup meeting on Friday, February 6, 2015 – SoftwareCPR® Partners Sherman Eagles and Alan Kusinitz gave a presentation at ONC’s request with recommendations on an approach to HealthIT provider quality systems regulation and standards. In addition to providing background on quality systems, SoftwareCPR® recommended that a standard or guidance be...
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ECRI Institute published its Top 10 Patient Safety Concerns for Healthcare Organizations to give healthcare organizations a gauge to check their track record in patient safety. The list originally appeared in its Healthcare Risk Control (HRC) System newsletter, the Risk Management Reporter, and is reprinted in this report. The list is partly based on more...
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Sherman Eagles of SoftwareCPR co-authored AAMI’s recently published article “Reducing Risks and Recalls: Safety Assurance Cases For Medical Devices” in the January/February 2014 issue of BI&T (Biomedical Instrumentation & Technology; a monthly, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation). The full article is posted with permission at the link provided. Any...
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The article “Build and Validate Safety in Medical Device Software”, available on the Medical Electronics Design Website at http://www.medicalelectronicsdesign.com or at the link provided above, provides an overview of the challenges and approaches to preventing and detecting software faults that can lead to hazardous situations. The article provides an overview of some of the relevant...
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On February 20, 2003, a final security rule 45 CFR Part 142 was issued. Subsequently HHS issued a series of educational documents regarding various aspects of the rule including administrative controls, physical controls, technical safeguards, risk management and others.  
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In the July 2006 IEEE Computer Journal article: “The Power of 10: Rules for Developing Safety- Critical Code” by Gerard J. Holzmann of the NASA/JPL Laboratory for Reliable Software, the following 10 rules were listed: 1. Restrict all code to very simple control flow constructs—do not use go to statements, set jump or long jump...
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This topic includes links to software safety guidance from other safety related industries that have useful information that could be applied to medical device software. All of these and sometimes others are in the document library section of the website.
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The US Department of Homeland Security (DHS) released software security information via a webpage, initiatives, and various documents related to software security. Some of this information (such as the paper on Security in a Software Lifecycle) may aid medical device IT and device software developers in designing in appropriate security and privacy measures to ensure...
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On February 20, 2003, a final security rule 45 CFR Part 142 was issued. A copy is at this link: HIPAA Final Security Rule 2003-02. Medical Device manufacturers that produce devices that will maintain patient data should be aware of HIPAA privacy and security requirements to assure appropriate features are incorporated in their devices to...
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On August 14, 2002, the HIPAA final privacy rule 45 CFR Parts 160 and 164 were modified to respond to comments and to reduce the administrative burden of the rule.  A copy of the new rule can be view here:  HIPAA Modified Final Privacy Rule 2002-08. Medical Device manufacturers that produce devices that will maintain patient...
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A NEMA presentation on HIPAA medical device issues is available here:  NEMA HIPAA Med Dev Issues Presentation. SoftwareCPR® provides on-site and web based training in HIPAA privacy and security regulations, in addition to other regulatory consulting services. SoftwareCPR® also provides a HIPAA Roadmap with links to relevant educational documents to paid subscribers (See Post HIPAA Privacy and...
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A NEMA paper on HIPAA medical device remote service issues is available here: NEMA HIPAA Med Dev Remote Services Paper. SoftwareCPR® provides on-site and web based training in HIPAA privacy and security regulations, in addition to other regulatory consulting services. SoftwareCPR® also provides a HIPAA Roadmap with links to relevant educational documents to paid subscribers (See...
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A NEMA paper on HIPAA is available here:  NEMA HIPAA Security Intro Overview. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was signed to law on July 21, 1996, and has the general objectives to: Guarantee health insurance coverage of employees Reduce health care fraud and abuse Introduce/implement administrative simplifications in order to augment...
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On December 28, 2000, a final privacy rule 45 CFR Part 160 and 164 was issued.  HHS provides the rule and related guidance here: https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html. Medical device manufacturers that produce devices that will maintain patient data should be aware of HIPAA privacy and security requirements to assure appropriate features are incorporated in their devices to allow...
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“A Methodology for Safety Case Development” was the result of a research grant. It discusses development of safety cases. Essentially development of justification for the safety of software in a given system/use. While FDA requires risk and software hazard analysis there is significant value, in our opinion (SoftwareCPR), in constructing rationale that demonstrates safety rather...
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