Working together to unlock the full potential of AI-enabled healthcare

OPINION:

Digital health innovation is creating opportunities to transform healthcare in ways that were difficult to imagine even a decade ago. Medical technology, including AI-enabled devices, is helping clinicians detect diseases earlier, personalize treatments and become more efficient, all of which improves patient experience and outcomes. As leaders across the medtech industry for decades, who currently serve as the AdvaMed Digital Health Tech Board of Directors, we have seen firsthand how innovation can improve patient care and benefit patient outcomes. We have also seen how policy can either accelerate or slow that progress.

Today, there is an opportunity to accelerate clinician and patient access to cutting-edge AI-enabled medical devices. Clinicians and industry innovators lack access to the full spectrum of patient data needed to unlock the full potential of AI-enabled healthcare. Medtech company R&D teams seek clear and efficient regulatory frameworks and predictable reimbursement pathways that keep pace with these rapidly evolving technologies.

Congress and the White House have an opportunity to advance these medtech AI-enabled innovations by enacting policy changes to facilitate continuum of care patient data access within our healthcare system. It is not an easy task, but if we get these policies right, the benefits for patients and the American healthcare system could be substantial not just for this generation but for future ones as well.

We can start by building on what is already working well. For decades, the U.S. Food and Drug Administration has evaluated software-driven and AI-enabled medical devices for safety and effectiveness across the total product lifecycle. Today, the FDA has already authorized more than 1,500 AI-enabled medical devices for marketing in the United States.

The FDA should remain the lead regulator for AI-enabled medical devices and should continue to evaluate and adapt its regulatory framework to keep pace with the advances in digital innovation, and the White House and Congress should support the agency’s efforts to oversee these rapidly evolving technologies. The agency’s expertise gives the United States a distinct advantage in a global race to apply AI in healthcare in ways that can improve patient outcomes and help to drive efficiencies for the clinician, the hospitals, the caregivers and the patients. Healthcare AI is fundamentally different from the consumer-facing tools Americans use every day. AI used to help diagnose disease, guide treatment and support a medical procedure must be evaluated in the clinical context in which patients and clinicians rely on it.

AI is already a valuable asset for clinicians. It can help reduce medical errors, increase accuracy and precision in surgical procedures, and bring efficiency to workflow and administration. To continually advance and improve, AI must know what “right” looks like, and that is achieved through access to data. In the years ahead, we must be able to get more granular and specific health data. The medtech industry already has adopted protocols to de-identify data and safeguard it, many of which are in use today. With greater data access, accuracy can improve, bias in models can be reduced and digital innovation can advance.

High-quality, representative data are essential to developing, validating, monitoring and improving AI-enabled medical technologies. Patients deserve confidence that their health information is protected and used appropriately, while innovators and clinicians need clear, consistent rules that support interoperability, uniform data standards, and responsible data-sharing practices. A patchwork of conflicting state requirements risks making it harder to build tools that work safely and fairly across diverse populations and care settings.

Congress should enact a federal privacy framework that protects patients while enabling responsible, uniform data access across a patient’s continuum of care. Consistent policies can help clinicians use technology more effectively, support model validation across real-world settings and reduce burdens on health systems already stretched thin by expanding access to good care in rural and underserved areas.

To inform design refinements for surgical procedure patients, doctors and medtech engineers should be able to learn from relevant preoperative, operative and postoperative data. Much of this information exists today, but is often scattered across various locations, with varying levels of access for clinicians and medtech engineers. True data access requires the stitching together of data across a patient’s journey in their continuum of care relevant to their surgical needs. The full picture is what will enable AI to drive improvements in the procedure and care. Unlocking that data must go hand in hand with robust privacy protections including appropriate de-identification and security safeguards so that patients can trust that their information is handled responsibly.

Governance structures for the responsible use of data are critical to data sharing and advancements in AI, and the private sector has a role to play here. The AdvaMed Digital Health Tech Board is developing voluntary Data Access Principles and Best Practices to promote trust, transparency, responsible data stewardship, and effective collaboration across the healthcare ecosystem. They will reflect a commitment by medtech companies to use data in ways that advance patient care and outcomes; enable innovation, including AI and advanced analytics; respect privacy and legal obligations across data types; and support collaboration with healthcare providers and facilities. We hope that once public, these Data Access Principles and Best Practices will help build trust and enable greater data sharing and collaboration across the healthcare system to ensure that patients can benefit from this next generation of healthcare.

With thoughtful policy that supports appropriate regulation and responsible data use, AI will continue to help detect disease earlier, personalize treatment, make care more efficient and accessible and improve the lives of millions of people. None of this means lowering standards. It means building the right standards: ones that protect patients, earn clinician trust, recognize the difference between medical and consumer AI and promote the development and evolution of transformative technologies.

We are already using AI-enabled devices, but there is so much more we can do. The medtech industry’s AI journey has tremendous potential, but many advances remain limited by barriers to data access. The potential for digital and AI-enabled devices to improve patients’ lives and deliver measurable clinical and economic benefits is real. Washington should act now to ensure patients can realize this potential.

• Robert Cohen is chairman of the Digital Health Tech Division Board of Directors at AdvaMed, the largest trade association for medtech and health tech innovators. He is also Vice President, Innovation and Technology, of the Orthopaedic Group at Stryker.