Although the HIPAA Privacy Rule directly effects “Covered Entities” medical device and pharmaceutical manufacturers may be involved in inadvertent release of private patient information and must deal with requirements from their customers that are Covered Entities. It was reported that: Eli Lilly, already has settled with eight states and the Federal Trade Commission for $160,000...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
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.