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...Read More
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...Read More
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.