Some top investors, entrepreneurs, and healthcare system executives believe new federal data-sharing regulations that went into effect in October and January could be massively important not only for clinical care, but also for businesses, given companies’ ever-increasing reliance on large datasets as a foundation for AI-driven medtech innovations.
The past decade has seen a huge influx of capital—the federal government estimates $30 to $40 billion—into our healthcare system to digitize America’s paper healthcare records and scale the use of electronic health records (EHRs). Although these efforts, initiated by the American Recovery and Reinvestment Act of 2009, paved the way for massive change, they fell far short of goals of achieving seamless access to and sharing of healthcare data, regardless of where it is housed. In practice, the law didn’t work entirely as anticipated, and, in 2016, when Congress passed the 21st Century Cures Act, it included reforms to address some of the shortcomings.
Since then, regulations to improve the original law have been slowly rolling out. Several key provisions went into effect in late 2022 and early 2023, which experts hope will change the landscape. Most significantly, as of October 6, 2022, healthcare systems must make all computerized patient data, not just EHRs, available to patients electronically—previously, that had not been the case. As of January 1, government mandates also require authorized software developers and healthcare systems to adhere to a universal framework for standardizing the sharing and management of healthcare data.