As the healthcare landscape adjusts to a new administration, clinicians face a range of potential policy shifts that could impact patient care, compliance, and operations. While healthcare innovation and regulatory efficiency may remain central themes, areas such as FDA oversight, drug pricing, and telehealth, and artificial intelligence (“AI”) are likely to see renewed focus. Providers should prepare for changes at both federal and state levels as new strategies are introduced to address affordability, access, and healthcare delivery.
One area to watch closely is the regulation of Lab Developed Tests (“LDT”). A recent rule expanding FDA oversight over LDTs has raised questions about its future implementation. Historically, these efforts have faced challenges, and a shift in enforcement priorities could lead to either delays or reconsideration of the rule. For clinicians relying on LDTs for diagnostics in areas like oncology and personalized medicine, any changes could reduce immediate compliance burdens but may create uncertainty around regulatory expectations moving forward.
In addition, drug pricing and affordability remain key policy concerns. Efforts to lower prescription drug costs may center on enhancing competition and improving supply chain efficiency. Measures such as medication importation and reforms to streamline pricing structures could gain traction, potentially improving patient access to essential therapies. However, as policies evolve, clinicians will need to stay informed to ensure they can help patients navigate new frameworks for affordability and coverage.
At the same time, telehealth policies are expected to undergo careful review. Expanded flexibilities during the pandemic allowed providers to deliver care across state lines, prescribe certain medications virtually, and access streamlined reimbursement pathways. Moving forward, there may be shifts to reintroduce more structured licensure requirements or place limits on virtual prescribing for specific treatments. Clinicians who rely on telehealth to provide care—especially in underserved or rural areas—should prepare for adjustments to current practices as the regulatory environment evolves.
The role of AI in healthcare is also expected to grow as innovations in clinical decision-making tools and medical devices accelerate. However, existing regulatory models may struggle to keep pace with rapid advancements. There is growing discussion about regulating AI in healthcare through a “platform-based” approach, meaning AI tools would be monitored as part of a broader system rather than individually. This would be similar to how laboratories are regulated under existing standards, where the overall quality and processes are assessed rather than each individual test or result. While such a shift could encourage innovation and streamline oversight, it may also place greater responsibility on developers to ensure safety and effectiveness. Clinicians adopting AI-based tools must remain aware of both the opportunities and potential risks that accompany these emerging technologies.
The next few years are likely to bring both opportunities and challenges as healthcare policies evolve. Changes in FDA oversight, medication affordability, telehealth flexibility, and access to therapies could shape how clinicians deliver care and support their patients. Navigating these shifts requires staying informed and proactive to ensure stability and compliance.
How Frier Levitt Can Help
Frier Levitt is committed to helping clinicians understand and adapt to the evolving healthcare policy landscape. Whether addressing regulatory changes, implementing new technologies, or navigating state-specific requirements, our team is here to provide the strategic guidance needed to position your practice for success. Contact us today to ensure you are prepared for the changes ahead and ready to seize new opportunities in healthcare delivery.
