Federal health regulators are set to unveil two major proposed regulations closely watched by health and technology companies, amid a growing flood of health data that has become an ever-more-valuable asset. The draft rules touch on a broad array of issues, including technology standards that are supposed to help unlock digital data stored in the electronic health records used by hospitals and doctors to track patients’ care.
The new proposals could benefit a growing list of companies including Apple Inc. that are building tools for patients to store real-time health information on their digital devices. Federal officials said they want to prod health care toward the digital norm in other industries like banking, where consumers routinely tap records on their smartphones. Today, patients are often forced to carry printouts or physical discs to a new doctor’s office.
“Patients have really lost in the system,” said Seema Verma, administrator of the Centers for Medicare and Medicaid Services, one of the agencies issuing the proposed rules. “Today, instead of filing cabinets and paper silos, we now have electronic silos” that make it difficult for patients to access their own health data.
One of the new proposals says that patients must be able to electronically access all of their health information held in a health-care provider’s electronic record, including details such as doctors’ notes, and the patient can’t be charged for the material. “The rule really is, OK, let’s figure out how to get this information out technically and let’s force it out,” said Don Rucker, the national coordinator for health information technology in the Department of Health and Human Services.
Today, hospitals generally offer online patient portals, but these often lack material such as doctor notes, imaging scans and genetic-testing data. Sometimes, hospitals and doctors charge for access to records, said Deven McGraw, a former federal official who is now an executive at Ciitizen, a startup creating an online tool for patients to pull together health data. “It’s very hard for individuals to get their health information today,” she said, despite existing law that protects such access.
The new proposals would also require health insurers offering government-backed plans such as Medicare Advantage, managed Medicaid and Affordable Care Act exchange coverage to open up new digital pathways to claims data for consumers, including information on costs of services. That could allow such data to be integrated into tools like Apple’s. Other companies trying to help patients access their health information include Ciitizen, Seqster and PicnicHealth, as well as UnitedHealth Group Inc., which is creating an individual health record. Insurers’ directories of doctors and hospitals would also need to be made available in that fashion.
Ms. Verma said she would encourage insurers to offer the same service in employer plans, and that if they don’t, legislation might be needed.
Health information long kept in paper records has been moving into the digital realm, pushed by billions of dollars in federal incentives. Now, the federal government says that at least 97% of hospitals have electronic health records, which are used to document everything from doctor visits to imaging scans.
Such digital information carries huge value. It can help improve patient care and convenience. But it also serves business imperatives such as keeping patients tied closely to particular hospital systems, developing valuable new artificial-intelligence-powered health-care tools, and allowing drug-industry studies of the real-world effects of medicines.
In 2016, after a federal report found that some health-care providers and electronic-health-records vendors had choked off the exchange of health data, Congress passed a law that included financial penalties for such information blocking. However, regulations had to be written for it to take full effect. “There have been roadblocks that prevent innovations and data from being widely shared where it could benefit patients,” said Julia Adler-Milstein, a professor at the University of California, San Francisco.
The new proposal carves out seven exceptions to the law’s mandate, when a company might legitimately decline to share data. Among them: when the health-data request would impose an unreasonable burden or violate health-privacy practices. The proposal would also impose new limits on health-data holders’ ability to charge other companies for access. They could still impose fees to recover certain costs they incur.
The 2016 law also said health-information-technology vendors such as electronic-medical-record companies couldn’t block others from sharing information related to their products’ usability and security, among other topics. The new proposal fleshes that out, allowing some narrow exceptions, but says companies can’t broadly ban sharing of screenshots. Safety experts have complained that prohibitions on such shots have sometimes limited efforts to communicate about problems.
The new proposal also includes a requirement for hospitals to provide digital notifications about patients who are admitted, transferred or discharged. These would go to other health-care providers that see those patients. The proposal makes such reports a condition of participating in the Medicare program, a very powerful regulatory hammer.
Currently, doctors often aren’t told when their patients are in the hospital, or when patients leave it, said Farzad Mostashari, a former federal health official who is now CEO of Aledade Inc., a company that helps doctors manage groups of patients. That can lead to problems, such as patients taking drugs they shouldn’t get after receiving a prescription from a hospital doctor. “Those can be really, really dangerous moments,” he said.