Tag

hipaa
We hope you find this Regulatory Roadmap on HIPAA Privacy and Security useful.
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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...
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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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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

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