Health Law Advisor

“Master Files” are not just for PowerPoints. On April 4, 2024, the Food and Drug Administration (FDA) issued its “New Dietary Ingredient Notification Master Files for Dietary Supplements: Guidance for Industry” (“Draft Guidance”). These latest recommendations build upon the agency’s Final Guidance issued in March—the subject of our prior blog post—regarding procedures and timeframes for industry stakeholders to submit NDINs. The new recommendations also replace and expand upon those portions of a 2016 Revised Draft Guidance, called “Dietary ...

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform important surgical tasks or sensitive or invasive procedures or examinations (“Guidance”). The Guidance aims to address increasing concerns over patient privacy, in particular the performance of sensitive examinations and invasive procedures on anesthetized patients.

The Guidance both revises the Hospital Interpretive Guidelines regarding ...

In our ongoing series of blog posts, we examine key negotiating points for tenants in triple net health care leases. We also offer suggestions for certain lease provisions that will protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective. In our first two blog posts, we considered the importance of negotiating initial terms and renewal ...

We recently wrote about proposed Oregon legislation that would have addressed workplace violence in healthcare settings but failed to move forward in the legislature due to concerns about a provision that would have made assault on a hospital worker punishable as a felony.

This was not a concern that troubled the Kentucky legislature, which on March 27, 2024, signed and delivered to the state governor a bill relating to workplace violence against healthcare workers. The Kentucky legislation expands the offense of assault in the third degree perpetrated against a variety of ...

Combination products present a tremendous opportunity to improve health outcomes, because they leverage multiple disciplines.  If we were, for example, to focus on drugs alone with little thought to how they might be delivered, we would be surely missing a chance to enhance safety or effectiveness.  Likewise, many devices can be made more effective or safer if paired with a drug.

At the end of 2016, FDA finalized a rule covering Postmarket Safety Reporting for Combination Products that now can be found at 21 C.F.R. Subpart B.[1]  A few years later, in July 2019, FDA finalized a guidance ...

On Monday, March 11, 2024, the Office of the National Coordinator for Health Information Technology’s (ONC) Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule went into effect. Among several elements of HTI-1, ONC promulgated “information blocking enhancements” which include new and updated definitions, as well as new and updated information blocking exceptions. Other sections of HTI-1 introduce algorithm transparency and replace “clinical decision support” ...

HRSA’s “Audit Reporting Requirement Attestations” arrived in inboxes on Friday, March 22, 2024, and require a response by Friday, April 5, 2024.  The government is under pressure to show that the money distributed under the CARES Act and the American Rescue Plan was used responsibly.  These notices are frustrating and frightening, and a two-week turnaround may seem a bit callous, but the situation could certainly be worse—the government could have simply demanded a return of the funds.  If an organization expended more than $750,000 in a single fiscal year and does not comply ...

Oregon’s HB 4088A, introduced in the state legislature during the 2024 session, died in the Joint Ways and Means Committee when the legislature adjourned on March 7. The legislation was intended to strengthen Oregon’s workplace violence prevention laws by adding regulatory requirements and enhancing the criminal repercussions for assault of hospital workers. While most of the bill had bipartisan support, section 6 of the proposed legislation, which would have made the assault of a hospital worker a felony instead of a misdemeanor, garnered strong opposition.

In this post ...

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others—to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug Pricing Program (the “340B Program” or the “Program”). Specifically, industry stakeholders have until April 1^st to submit comments to legislators regarding the Discussion Draft Explanatory Statement and Supplemental RFI (the “RFI”) of the “Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now ...

On March 13, 2024, Indiana Governor Eric J. Holcomb signed Senate Enrolled Act No. 9 (“SEA 9”) which will amend the Indiana Code with respect to notice of health care entity mergers and acquisitions.

The measure, effective July 1, 2024, adds a new Chapter 8.5 to the Indiana Code providing in Section 4(a) that “[a]n Indiana health care entity that is involved in a merger or acquisition with another health care entity with total assets, including combined entities and holdings, of at least ten million dollars ($10,000,000) shall, at least ninety (90) days prior to the merger or ...