Health Law Advisor

On January 20, 2025, a new administration took control of the Executive Branch of the federal government, and it has signaled that it will make aggressive use of executive orders.  This would be a good time to review the scope of executive orders and how they may affect employers and health care organizations.

Executive orders are not mentioned in the Constitution, but they have been around since the time of George Washington. Executive orders are signed, written, and published orders from the President of the United States that manage and direct the Executive Branch and are binding on Executive Branch agencies.  Executive orders can be used to implement or clarify existing federal law or policies and can direct and manage the way federal agencies interact with private entities.   However, executive orders are not a substitute for either statutes or regulations.

The current procedure for implementing executive orders was set out in a 1962 executive order that requires that all such orders must be published in the Federal Register, the same publication where executive agencies publish proposed and final rules. Once published, any executive order can be revoked or modified simply by issuing a new executive order.  In addition, Congress can ratify an existing executive order in cases where the authority may be ambiguous.

On October 23, 2024, Dr. Jill Biden, first lady of the United States,  announced the winners of $110 million in awards on behalf of the Advanced Research Projects Agency for Health (ARPA-H) to accelerate transformative research and development in women’s health.

“It’s time for investors, researchers, and business leaders to have [conversations about women’s health], not as an afterthought but as a first thought,” Dr. Biden said in her prepared remarks. “Those kinds of questions belong in your research proposals, in your laboratories, in your pitch decks.”

The awards will go to 23 teams from small startups to global innovators working to further developments in women’s health—with projects ranging from a non-invasive blood test to diagnose endometriosis to a revolutionary treatment for late-stage and metastatic ovarian cancer.

On October 30, 2023, President Joe Biden signed the first ever Executive Order (EO) that specifically directs federal agencies on the use and regulation of Artificial Intelligence (AI). A Fact Sheet for this EO is also available.

This EO is a significant milestone as companies and other organizations globally grapple with the trustworthy use and creation of AI.  Previous Biden-Harris Administration action on AI have been guidance of principles (e.g., the AI Bill of Rights) or have been targeted guidance on a particular aspect of AI such as the Executive Order Addressing Racial ...

In this episode of the Diagnosing Health Care Podcast:   With the recent midterm elections changing the composition of Congress, and the Biden administration’s first opportunities to advance its policy priorities from the very beginning of the rulemaking process, what are the key health care developments to watch out for in 2023?

Epstein Becker Green attorneys Ted Kennedy, Jr.; Alexis Boaz; and Philo Hall discuss the current landscape of health care policy from both the legislative and regulatory perspectives and analyze which key health care issues may arise.

In this episode of the Diagnosing Health Care Podcast:  We’re beginning to see how mergers and acquisitions in the hospital industry are being impacted by President Biden’s executive order promoting competition in the American economy. The Federal Trade Commission recently announced policy changes, and the Department of Justice has been asked to consider policy changes, that boards of directors and C-suite officers must take into account when weighing transactions.

Special guest Dr. Subramaniam (Subbu) Ramanarayanan, Managing Director at NERA Economic Consulting ...

On May 17, 2021, the U.S. Department of Justice (“DOJ”) announced the establishment of a COVID-19 Fraud Enforcement Task Force (“Task Force”) to ramp up enforcement efforts against COVID-19-related fraud.[1]

Organized and led by Deputy Attorney General Lisa Monaco, the Task Force convened its first meeting on May 28 and aims to “marshal the resources of the [DOJ] in partnership with agencies across government to enhance enforcement efforts against COVID-19 related fraud.”[2]  The Task Force will involve coordination among several DOJ components, including the Criminal and Civil Divisions, the Executive Office for United States Attorneys, and the Federal Bureau of Investigation.  “Key interagency partners” have also been invited to join the Task Force, including the Department of Labor, the Department of the Treasury, the Department of Homeland Security, the Social Security Administration, the Department of Veterans Affairs, the Food and Drug Administration’s Office of Criminal Investigations, the U.S. Postal Inspection Service, the Small Business Administration, the Special Inspector General for Pandemic Relief, and Pandemic Response Accountability Committee, among others.

New from the Diagnosing Health Care Podcast:  The Biden administration has invoked the Defense Production Act ("DPA") to speed up the production of vaccines and increase the domestic production of COVID-19 tests, personal protective equipment (or “PPE”), and other essential supplies. Epstein Becker Green attorneys Neil Di Spirito, Constance Wilkinson, and Bonnie Odom discuss the administration's reliance on the DPA as it continues to operationalize its pandemic response, and the challenges these actions are likely to present for medical product suppliers.

In this episode of the Diagnosing Health Care Podcast, dive into the Biden Administration's first 100 days in office and the potential executive orders, regulations, and new legislation with noteworthy health care policy implications.

Epstein Becker Green attorneys Ted Kennedy, Philo Hall, and Paulina Grabczak discuss President Biden’s priorities, including his COVID-19 response plan, and examines which "midnight rules" put in place by the Trump Administration could be intercepted or retained.

The Diagnosing Health Care podcast series examines the business ...