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Life Sciences Legal Update Blog

Articles: 1-10 of 118

Proposed Rule Offers Clarity on Mandatory Protections for Substance Use Disorder Patient Records

USA - September 15 2019 Entities that provide treatment to patients with substance use disorders may find some clarity on federal requirements surrounding patient record…

Recent Traction In FDA’s Development of the 503A and 503B Bulks Lists

USA - September 9 2019 Just as the U.S. Food & Drug Administration (“FDA”) promised in its 2019 compounding priorities statement, FDA published a notice and proposed rule…

About That Brand Memo . . .

USA - August 22 2019 Issued in January 2018, the so-called Brand Memo reminded Department of Justice (DOJ) attorneys that “[g]uidance documents cannot create binding…

Cannabis Regulation: Trending Towards Change in the UK?

Canada, United Kingdom - August 15 2019 Following a recent fact-finding trip to Canada undertaken by three British MPs interested in understanding the effects of a more relaxed regulatory…

Newly introduced bill could provide for additional protections for biological data collected by non-covered entities

USA - July 8 2019 Over the past few years, genetic testing services have become a widespread phenomenon. Companies providing these services gather certain biological…

HIPAA-Regulated Entities Take Notice - States are Teaming Up on Enforcement

USA - June 27 2019 In an unprecedented settlement arising from a federal lawsuit in the U.S. District Court for the Northern District of Indiana, a medical software…

Munich Regional Court Clarifies When Claims for Transfers of Patents Become Time-Barred

Germany - June 19 2019 Germany is one of the most important patent litigation jurisdictions in Europe, making developments in its patent law very important to life sciences…

Five Key Takeaways from OCR’s Proposed Rule to Scale Back the Non-Discrimination Requirements Applicable to Health Care Entities

USA - June 13 2019 The Department of Health & Human Services (HHS) Office for Civil Rights (OCR) recently issued a proposed rule (Proposed Rule) that would…

OCR Clarifies Direct Liability of Business Associates Under HIPAA

USA - May 29 2019 The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new fact sheet outlining and clarifying violations of HIPAA…

Health Apps and HIPAA - Recent FAQs Highlight Importance of Covered Entities and Business Associates Scrutinizing their Relationships with App Developers

USA - May 16 2019 The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new set of HIPAA FAQs addressing the applicability of HIPAA…