En Banc: Federal Circuit Provides Guidance On Application of On-Sale Bar to Contract Manufacturers

En Banc: Federal Circuit Provides Guidance On Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).

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“I Want My PHI”, Part 2 – OCR Audits Will Focus On Individual Access Rights

By | HIPAA, HITECH & HIT | July 15, 2016
“I Want My PHI”, Part 2 – OCR Audits Will Focus On Individual Access Rights

We blogged on this back in early May, but compliance with individuals’ rights to access their PHI under HIPAA is even more critical now that OCR has announced that its current HIPAA audits will focus on an audited Covered Entity’s documentation and process related to these access rights.

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