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New HIPAA Privacy Rule Guidance

Client Alert | less than 1 min read | 12.04.02

The Department of Health and Human Services' Office of Civil Rights (OCR) has released a 100+ page guidance document on the HIPAA Privacy Rule. The guidance document discusses a broad array of topics in a Q&A format. OCR is the agency responsible for enforcing the Privacy Rule, so this guidance provides useful insight about the government's approach to some of the Privacy Rule's "hot topics". For example, OCR states that physicians with hospital staff privileges need not enter into business associate contracts with the hospital, because joint physician-hospital activities fall under the definition of "organized health care arrangement".

Insights

Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....