Medical device manufacturers, who may already be seeing the effects of lessened demand stemming from a slow-down of elective procedures outside of the United States, should be aware of recent guidance the U.S. Centers for Medicare and Medicaid Services (CMS)
Life Sciences Legal Update
Analysis & commentary by Reed Smith on trends & developments in life sciences & health care law
Latest from Life Sciences Legal Update - Page 3
European Commission Recommendation Could Expedite Access to Medical Devices, Personal Protective Equipment Needed to Care for COVID-19 Patients
If they serve health care professionals (HCPs) in EU member states, manufacturers that provide personal protective equipment (PPE) or medical devices used by HCPs caring for known or suspected COVID-19 patients should familiarize themselves with a recent European Commission recommendation.…
German Constitutional Court Rules Germany’s Ratification of the Agreement on a Unified Patent Court is Void
Global life sciences companies have been carefully watching the European effort to launch a Unified Patent Court (UPC). As we discussed in a previous post, the UPC would have a profound effect on how life sciences companies set about…
Health Care Providers, Health Plans, and Health IT Developers Sharing Patient Data Likely Impacted by New Final Rules
By Lisa Baird
Certain health care providers, health information technology (IT) developers, and health plans could see the way they share patient information transformed following the release of two new final rules issued by the U.S. Department of Health and Human Services. The…
COVID-19’s Potential Impact on Continuation of Business Relationships in France
As corporations continue to grapple with economic issues surrounding COVID-19, global life sciences companies must start to determine how laws in each of the jurisdictions in which they operate will impact their contractual responsibilities and opportunities for remedies in their…
EU funding call for Coronavirus projects
The Innovative Medicines Initiative (IMI) was created in 2008 as a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).[1] Its overall goal is to increase the competitiveness of R&D in the…
United States federal and state rules and regulations during public health emergencies: navigating novel coronavirus
On January 30, 2020, the World Health Organization (WHO) declared novel coronavirus (also known as “2019-nCoV” and “SARS-CoV-2”) a Public Health Emergency of International Concern, and the United States Department of Health and Human Services (HHS) named it a public…
Court of Justice of the European Union delivers rulings on market authorisation applications
The Court of Justice of the European Union (CJEU) upheld decisions by the European Medicines Agency in two identical rulings on January 22, 2020. In the cases of PT Therapeutics International v. EMA (C-175/18 P) and MSD Animal Health Innovation…
FDA announces information collection on “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion”
On January 28, 2020, the Food and Drug Administration (FDA) announced that the Office of Prescription Drug Promotion (OPDP) will conduct two studies to examine how payment disclosure statements and the types of endorsers in drug advertisements affect consumers’ understanding…
Health care and life sciences companies may gain clarity from proposed amendment to California Consumer Privacy Act (CCPA)
Proposed amendment AB 713, if passed, would hopefully provide clarity to businesses working with clinical research data. The amendment proposes matching CCPA de-identification standards to those set forth in the Health Insurance Portability and Accountability Act (HIPAA), in addition…