On March 27, 2023, the U.S. Food & Drug Administration (FDA) released two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19 Public Health Emergency (PHE), and (ii)
Health Care Law Today
Health Care Law Today, published by Foley & Lardner LLP, focuses on legal developments and regulatory issues affecting the healthcare industry. The blog covers topics such as digital health investment trends, telehealth privacy and security best practices, Medicare policy changes including behavioral health service expansions, remote patient monitoring regulations, and compliance with state vaccination requirements for healthcare facilities. It addresses the intersection of healthcare delivery, technology, and law, providing updates on federal and state regulations, reimbursement policies, and risk management strategies relevant to healthcare providers, payers, and investors.
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FDA Publishes Framework for Digital Health Technologies in Clinical Trials
On March 23, the U.S. Food and Drug Administration (FDA) published a framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials.
DHTs include a wide array of technologies, including software applications that…
Foley & Lardner Comment Letter on DEA Telemedicine Controlled Substance Proposed Rule
On March 1, 2023, the Drug Enforcement Agency (DEA) officially published proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The DEA gave the public a 30 day window to submit comments, after which…
The Future of the 340B Program: 2023 Key Decisions
Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care providers, referred to as “covered entities.”…
Growing Scrutiny of Private Equity in Health Care
The presence of private equity (PE) investment has exploded in recent years in all areas of the health care sector. PE in health care is a good thing when done right: It can pave the way for much needed innovation,…
Considerations When Conducting Decentralized Clinical Trials
Although use of telehealth in clinical trials is not new, the modality was not popularized until social distancing efforts brought about by COVID-19 forced the issue.
Companies interested in providing clinical trial services via telehealth have to deal with whether…
The BioPharma Patent Cliff: 2023 and Beyond
A “patent cliff” refers to the end of IP protection for a drug that has enjoyed market exclusivity since its launch. Various types of regulatory exclusivity can occasionally lengthen the protection for drugs, but generally when a drug loses patent…
2023 Telemedicine & Digital Health Trends
Medicare telehealth post-Public Health Emergency (PHE): With the COVID-19 PHE concluding on May 11, 2023, many of the telehealth flexibilities the Centers for Medicare & Medicaid Services (CMS) implemented during the PHE will sunset at varying times. For example: CMS will…
Building Biotech with Brains: Strategies for Maximizing Value of AI-Driven Biotechnology Inventions
The rapid rise of artificial intelligence (AI) and machine learning (ML) in biotechnology products and services is becoming a driver of the personalized medicine and health care sectors. While this integration can require special consideration during development of a patent…
Antitrust: DOJ Scuttles ACO Guidance, Unsettles Ground under Provider Joint Contracting Models
On Friday, February 6, 2023, the Department of Justice (DOJ) announced the withdrawal of the 2011 Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (2011 ACO Statement) in addition to two other…