According to the U.S. Court of Appeals for the Federal Circuit’s August 5th ruling in Thaler v. Vidal, No. 2021-2347 (Fed. Cir. 2022), artificial intelligence (“AI”) cannot be named as an inventor on a U.S. patent application. In its opinion, the Federal Circuit considered whether an inventor of a U.S. patent can be anything other … Continue Reading
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. This recommendation is designed to accelerate the time to market for these products, provided that … Continue Reading
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 European pharmaceutical sector by encouraging companies to work with each other and with the public sector. … Continue Reading
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 to equally important clarifications for life sciences companies, health care providers and medical researchers. In particular, … Continue Reading
On Wednesday, November 20, a three-judge panel of the U.S. Court of Appeals for the Eleventh Circuit heard oral argument in the closely watched False Claims Act (FCA) case of United States ex rel. Ruckh v. Salus Rehabilitation, Inc. The case involves questions regarding how to interpret and apply the FCA’s materiality standard set forth … Continue Reading
As 2019 comes to an end, the United States Food & Drug Administration’s (“FDA” or the “Agency”) Center for Veterinary Medicine has published a new draft Guidance for Industry #256, “Compounding Animal Drugs from Bulk Drug Substances” (the “Draft Guidance”). The Draft Guidance addresses FDA’s regulatory approach to compounding animal drugs from bulk drug substances. … Continue Reading
Reed Smith will be hosting an upcoming webinar, “12 Months in Health Care Law: A Roller Coaster Journey”, on Tuesday, October 15, 2019 at 12:00 PM ET. The webinar will deliver an informative and entertaining review of many of the key regulatory developments and court rulings in health care law over the past 12 months. … Continue Reading
On October 2, 2019, the United States Food & Drug Administration (FDA) announced that it awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to establish an information-sharing system for drug compounding activities conducted in accordance with Section 503A of the Federal Food, Drug, & Cosmetic Act (FDCA). With this … Continue Reading
Entities that provide treatment to patients with substance use disorders may find some clarity on federal requirements surrounding patient record confidentiality. The Department of Health & Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) recently announced much-anticipated proposed changes to the federal regulations at 42 C.F.R. part 2 (Part 2), which govern … Continue Reading
As a part of our FDA Series, Reed Smith will be hosting an upcoming webinar, “The changing regulatory landscape of promotion: Drug/biologic advertising in the Trump era and beyond” on Thursday, September 19, 2019 at 2:00 PM ET. This program will discuss promotional enforcement activity under the Trump Administration and how recent technological, demographic, and … Continue Reading
Following a recent fact-finding trip to Canada undertaken by three British MPs interested in understanding the effects of a more relaxed regulatory environment for cannabis, the MPs predicted the UK would legalize cannabis for adult use in the next decade. As the potential offered by the cannabis industry continues to intrigue more and more life … Continue Reading
Over the past few years, genetic testing services have become a widespread phenomenon. Companies providing these services gather certain biological data from consumers who sign up for their services and then analyze this data to ascertain information about the consumer’s ancestry and/or genetic traits, among other things. These companies, however, are typically considered “non-covered entities” … Continue Reading
In an unprecedented settlement arising from a federal lawsuit in the U.S. District Court for the Northern District of Indiana, a medical software provider agreed to pay $900,000 to 16 state attorneys general (AGs) for alleged violations of a conglomerate of state and federal privacy laws. The settlement represents the resolution of the first-ever multistate data … Continue Reading
Life sciences companies doing business in France will be interested in the recent results of Optical Center’s appeal of a penalty assessed by the Commission nationale de l’informatique et des libertés, the French data protection authority, surrounding a data breach. The data breach allowed access to invoices and purchases containing personal and sensitive customer data. … Continue Reading
The Supreme Court of the United States heard oral argument on March 27, 2019 concerning a case (Kisor v. Wilkie, No. 18-15) involving the Department of Veteran Affairs (VA). The case asks the Supreme Court to consider overruling the current doctrine which allows an agency to interpret its own regulation unless it is clearly incorrect. … Continue Reading
Following the issuance of the “Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation in the Industries of Pharmaceuticals and Medical Devices” by the Central Office of the Communist Party of China and the Office of the State Council on October 1, 2017, the former China Food and Drug Administration** formulated … Continue Reading
Chicago Partner Rachael Pontikes of Reed Smith’s Life Science Health Industry group will speak at the Food and Drug Law Institute’s (FDLI) Drug Quality Security Act Conference on November 15 in Washington D.C. The conference will include panels of government regulatory and industry experts discovering current issues surrounding the DQSA’s Title I Compounding Quality Act … Continue Reading
On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides a list of all the drugs that outsourcing facilities have compounded; (2) publishing a guide entitled “Outsourcing Facility Information,” which is a compilation of key … Continue Reading
Two members of Reed Smith’s Life Sciences Health Industry (LSHI) group will be speaking at the American Conference Institute’s 4th Annual Conference on Women Leaders in Life Sciences Law taking place in Boston on July 20-21, 2017. On Thursday, July 20, 2017, Reed Smith Partner Katie Pawlitz will be a panelist for the conference’s “Year … Continue Reading
The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “12 Months in Health Care Law: A Roller Coaster Journey” on October 25, 2016 at 12:00 p.m. ET. Please join Reed Smith Partner Elizabeth Carder-Thompson as she presents her annual informative and entertaining review of many of the key regulatory … Continue Reading
Two members of Reed Smith’s Life Sciences Health Industry (LSHI) group will be speaking at the American Conference Institute’s 3rd Annual Conference on Women Leaders in Life Sciences Law taking place in Boston on July 27-29, 2016. On July 28, Reed Smith partner and co-chair of the firm’s LSHI group, Melissa A. Geist will discuss … Continue Reading
By Jennifer Pike and Brad Rostolsky on Posted in Privacy & HIPAA
In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool has been released that is designed to help developers of mobile health apps understand the multitude of federal laws and … Continue Reading
As previously discussed here and over on Health Industry Washington Watch here, this past Thursday, CMS and OMB issued the final, 600+ page Medicaid Rebate Program Final Rule. The pre-Federal Register version of the final rule may be accessed here. While we are still processing what this will mean for drug manufacturers and other health … Continue Reading
Recently, the Centers for Medicare & Medicaid Services (CMS) released final regulations under the physician self-referral law known as the Stark Law. We previously discussed the topic here, on our Health Industry Washington Watch blog here and in a American Health Lawyers Association Weekly article “CMS Publishes Final Stark Law Regulations” written by Karl Thallner and Nicole … Continue Reading
