The Reed Smith Life Sciences Legal Update blog has been updated to reflect a variety of recent developments of interest, including:
- A Comparison of the French and U.S. Sunshine Acts. To help global manufacturers navigate the complex new reporting and disclosure requirements under the French and U.S. Sunshine Acts, Reed Smith Partners Elizabeth Carder-Thompson and Daniel Kadar created an at-a-glance summary chart comparing and contrasting the reporting requirements and how each act differs in its attempt to create transparency for patients when they are making decisions regarding their medical treatment. For details see https://www.lifescienceslegalupdate.com/2014/04/articles/regulatory-developments/a-comparison-of-the-us-and-french-sunshine-reporting-requirements/.
- Increased Government Regulation on Cosmetic Procedures in the UK. In response to an April 2013 independent review concerning the regulation of cosmetic interventions, the UK government released a response report in February 2014 detailing significant changes to improve the quality of care and information available to patients when undergoing cosmetic procedures. Authors John Wilkinson, Nicola Maguire, Adam Lewington and Daryl Cue review in detail the proposed regulatory changes. For details see https://www.lifescienceslegalupdate.com/2014/04/articles/regulatory-developments/uk-government-addresses-lack-of-regulation-and-legislation-in-cosmetics-industry/.
- OCR Announces HIPAA Enforcement Settlement Against County Government. On March 7, 2014, the HHS Office for Civil Rights announced its first settlement and corrective action plan with a county government. Skagit County in northwest Washington State has agreed to pay $215,000 to settle potential violations of the HIPAA Privacy, Security and Breach Notification Rules. Authors Brad Rostolsky, Nan Bonifant and Jen Pike discuss this case and what local and county governments need to be aware of in order to comply with HIPAA regulations. For details see https://www.lifescienceslegalupdate.com/2014/04/articles/data-privacy/county-governments-not-immune-from-hipaa-enforcement-ocr-announces-215000-settlement-with-skagit-county-washington/.… Continue Reading
New posts to Life Sciences Legal Update cover a Senate committee hearing on DTC ads for medical devices, the DOJ's revised its Principles of Federal Prosecution of Business Organizations, the business climate for pharmaceutical manufacturers, House Energy and Commerce Committee action on more than 7 health policy bills, and the overlooked implications of the FTC's Red Flag Regulations for the life sciences and health care industry. These posts, and more, are in keeping with the site's inter-disciplinary scope grounded in the recognition that legal issues are intertwined with business concerns, and rarely confine themselves to narrowly proscribed practice areas.… Continue Reading
Over the years, the lawyers at Reed Smith who represent clients in the life sciences and health industry have published newsletters like Product Liability Update and Health Law Monitor to keep clients informed about key litigation, transactional, and regulatory developments. We now have decided to take advantage of a blog format to make our content more accessible … Continue Reading