A digital revolution in the healthcare industry has begun and will transform discovery and delivery of healthcare in the coming years. While the U.S. set the trend for adoption and use of health information technology, we risk losing the global race to innovate without policy changes that support the evolving landscape.
From developments in artificial intelligence to remote patient monitoring devices, digital health promises to improve patient outcomes and make healthcare more accessible, convenient and affordable. Yet the most promising new technology coming out of U.S. research and development labs is facing a regulatory regime that was designed before the advent of these technologies, and the uncertainty of the legal landscape may limit the development and use of such innovation in healthcare.
It is time for stocktaking. We need public policy approaches that promote digital health innovation with the flexibility to adapt to new opportunities embarked on by healthcare and technology communities in the future.
The U.S. must chart a clear path for the fast-moving digital health revolution. We have identified 10 key policies that governments must get right to ensure the innovations in digital health can meet the needs of patients and clinicians alike. These include ensuring data quality and integrity, ensuring patient rights and consumer protection and enabling innovative public-private partnerships, among others.
A critical policy to get right is in the area of privacy and data use. Governments must balance novel uses of data to advance medical discoveries and improve patient health, with protection of patients’ privacy.
Currently, much U.S. health information is regulated by HIPAA. While groundbreaking at the time, HIPAA was developed two decades ago—before most hospitals used digitized records, before smartphones, and even before the big technology players became household names.
As technology advanced, policymakers have looked at issues only incrementally. They have not fully considered the way specific permitted purposes align with the new uses of health data. Now, innovative companies with a great idea have to spend significant effort to fit their idea into a framework that was never designed with them in mind. This leads to unusual arrangements and risk mitigation strategies that don’t necessarily maximize the benefits of the technology or the trust needed to support innovation.
But policy efforts designed to address innovation can result in uncertainty. Indeed, the new California Consumer Protection Act (CCPA) has inadvertently resulted in confusion about whether to comply with prior rules or new rules regarding healthcare data collected by digital tools and researchers.
California just ended its legislative session without fixing some of the problems and ambiguities regarding CCPA and health data. This leaves it to others to try to navigate the vagaries thereby potentially limiting innovations. As the U.S. considers a possible comprehensive federal privacy law, we must learn from the lessons of the CCPA as it affects health data.
We see new policies being developed within Southeast Asia, Japan, India and APEC around health data and the digital revolution. As a leader in the field, the U.S. has an important role to play in not only getting our domestic rules right but in serving as a model for others. For example, the U.S. Food and Drug Administration is developing innovative approaches for oversight of digital health technology, but we know that differences in global oversight must be harmonized so American innovation can scale.
While the U.S. led the push for adoption of health information technology, it will quickly fall behind if we watch while other countries seek creative regulatory approaches.
Uncertainty limits innovation. Tech entrepreneurs know this. Hospitals know it too.
In a healthcare industry that has been slow to adopt technology, the regulatory requirements proved only to slow adoption even further. While we have seen uncertainty play a role, we believe these challenges will be exacerbated as innovators increasingly use artificial intelligence and machine learning, which will raise new questions in healthcare such as how bias may become built into healthcare technology. We must develop adaptive, principled, comprehensive policy approaches that free up innovators and healthcare entities alike to focus on improving healthcare services and outcomes.
Government can help provide the guardrails and the basic rules to enable development, adoption and consumer protection for digital health technologies and data use. It’s time for leadership and for patients, providers, innovators and the government to come together to develop this framework so the U.S. can lead the digital health revolution.
If America is going to lead the digital revolution—and certainly in the important area of health—more must be done to provide clarity and ensure adaptability of policy that works domestically and a path that other governments can emulate.
Jodi Daniel, a partner at Crowell & Moring was the founding director of the Office of Policy at the Office of the National Coordinator for Health Information Technology and the first senior counsel for health information technology at the U.S. Department of Health and Human Services.
Ambassador Robert Holleyman, a partner at Crowell & Moring, is president and CEO of C&M International, a former Deputy U.S. Trade Representative, the former CEO of BSA/the Software Alliance, and counsel in the U.S. Senate.