Washington Health Care Conference Agenda
Monday, March 11, 2024
Time |
Event |
|---|---|
9:30 a.m. - 10:00 a.m. |
Registration |
10:00 a.m. - 10:10 a.m. |
Welcome
|
10:10 a.m. - 10:50 a.m. |
Session 1: FDA’s Latest Draft Guidance on Off-Label Communications – Inching Closer to Truth as a Viable Guiding Principle for Addressing Off-Label Information from Regulated Manufacturers In this session, our panelists will discuss October 2023 FDA draft guidances expanding the ability of regulated manufacturers to communicate with health care providers, as well as prospective third-party payors truthful information about the risks, benefits, and costs of off-label uses of drugs and medical devices. The presentation will address FDA’s proposed expansions of modes of communication, forms of information (particularly online), and intended audiences. It will also cover the precautions FDA would require to ensure that the expanded speech remains truthful and not misleading. The panel will discuss these issues against the legal backdrop of court decisions that have protected truthful speech under the First Amendment while allowing FDA to treat such speech as evidence of illegal intent to violate the FDCA as an adjunct to criminal prosecutions primarily involving illegal conduct and false or misleading off-label related speech. |
10:55 a.m. - 11:55 a.m. |
Session 2: Enforcement Trends in the Pharmacy Industry: What You Need to Know Pharmacies, whether they be national chains, small retail shops, or compounding facilities, face regulatory and enforcement scrutiny from a wide range of sources. This session will cover the sources of enforcement in the pharmacy space and discuss the latest federal and state enforcement trends impacting the industry. We will also discuss potential strategies to help mitigate risks and/or defend against allegations of non-compliance.
|
11:55 a.m. - 12:00 p.m. |
Break |
12:00 p.m. - 12:45 p.m. |
Fireside Chat: Beyond the Breach: Safeguarding Healthcare Data in the Digital Age Data breaches have unfortunately become a common occurrence in the healthcare industry. The global healthcare sector saw the highest costs of data breaches for the third year in a row, averaging $11 million and untold reputational damage. The root cause of these breaches? More often than not, credential services that process hundreds of millions of validation requests daily are to blame. As we’ve come to learn, the centralized storage of private user credentials is the weakest link in security. Hear from Badge cofounder Dr. Tina Srivastava, published author, renowned expert on innovation and secrecy, and a literal rocket scientist – on the impact that emerging novel privacy technologies are having in reshaping healthcare security. Discover how embracing digital privacy measures can help mitigate data breaches, safeguard patient confidentiality, and propel the industry toward a more secure future.
|
12:45 p.m. - 1:15 p.m. |
Lunch Buffet |
1:15 p.m. - 2:00 p.m. |
Session 4: Risk, Reward and Mitigation: Adapting Business Strategies in the Current Enforcement Environment This session will include a discussion of:
|
2:05 p.m. - 2:50 p.m. |
Session 5: State of Play: FDA Enforcement and Transactional Considerations in the Biotech and Digital Health Industries This session will discuss FDA regulatory updates and enforcement trends in the biotech and digital health industries and related issues to consider during due diligence in corporate transactions.
|
2:50 p.m. - 3:00 p.m. |
Break |
3:00 p.m. - 4:00 p.m. |
Program Keynote – José Morey |
4:00 p.m. - 5:00 p.m. |
Cocktail and Networking Reception |