New Trump rules aim to fuel sharing of patient health records by smartphone

President Trump’s top health care aides on Monday said they will finalize federal rules requiring health providers and insurers to make health records available to patients in an easily accessible electronic format, a policy shift aimed at fueling broader efforts to use patient data to develop new software tools and services.
In a briefing with reporters, Trump’s aides essentially doubled-down on policies they first announced last March, saying they will press forward with the rules despite warnings from electronic health record companies and some hospitals that they could compromise the privacy of patient information.
“Health care providers will be required to provide easy digital access to your records at no cost,” said Alex Azar, Trump’s health secretary, adding that the information will be made available through smartphones to allow it to be shared easily with app developers. “We hope to see a whole ecosystem of condition or disease-specific apps to help patients monitor and improve their health in real time.”

The rules are meant to accomplish for health data what the creation of the federal interstate system did for automobiles in the 1950s: They seek to set up a standardized infrastructure that will increase the pace and volume of traffic, supporting commerce and innovation through expanded access to health information.
But the level of access the rules provide can also have drawbacks in terms of security and privacy, especially in an era when these sensitive data are being monetized by massive technology companies seeking to grab a greater share of the nation’s $3.5 trillion health care industry.

The Trump administration did make some changes in response to privacy concerns raised over the past year, enabling hospitals and insurers to warn consumers about apps that fail to meet privacy standards. The rules also require that patients be given clear information about the uses they are consenting to when they provide their information to third-party technology companies and app developers.
“Privacy and security are paramount,” said Seema Verma, the administrator of the Centers for Medicare and Medicaid Services. “… These tools ensure that [health] plans and [app] developers have the technical tools they need to build secure application interfaces.”
The rules, most of which will go into effect in 2022, are broadly aimed at unlocking access to health data that are now trapped in silos controlled by hospitals, health insurers, and vendors of electronic health records. Over the last decade, federal taxpayers have spent $48 billion to digitize these data, but those digital records are mainly used for billing purposes and inaccessible to patients and other parties.
The federal efforts to make the information more available and portable are a boon to digital health startups and large technology companies such as Amazon, Microsoft, Facebook, Apple, and Google, which are seeking to leverage patient data to disrupt health care delivery using artificial intelligence and other software tools.
In a call with STAT after Monday’s press briefing, Verma said she expects the rules will make developing novel software products faster, easier, and less expensive.
“What this rule does is unleash that data and allows patients to have access to it and allows them to direct where they want it to go,” she said. “In an era of artificial intelligence, we have an ability to analyze this data to advance medical science, and to advance clinical guidelines that provide better, more personalized services, hopefully at a lower cost.”
Monday’s announcement seeks to implement provisions in the 21st Century Cures Act that seek to make health records accessible to patients and prevent so-called information blocking by health care entities that tend to guard patient data for their own commercial purposes. Two sets of final rules were released, one from the Centers for Medicare and Medicaid Services, and another by the Office of the National Coordinator for Health Information Technology.

Epic, the nation’s largest seller of electronic health records, which had forcefully criticized an earlier version of the rules, issued a brief statement Monday that didn’t comment on the new policies specifically: “We have been working closely with HHS and ONC to try to improve the rule, and we appreciate their willingness to hear our feedback,” the statement said, referring to the federal agencies in charge of drafting the regulation.
While administration officials trumpeted the rules as a historic shift that will fuel data accessibility and innovation, their impact on the marketplace remains to be seen. Several presidential administrations have tried — and failed — to create a freer exchange of health data that would ultimately benefit patients, a concept known as data interoperability. But many health care organizations, including insurers, hospitals, and health record vendors, have effectively blocked those prior efforts because of concerns about privacy, excessive red tape, and their own financial interests.
Health data specialists who have been following the development of the rules said there is reason to be optimistic this time around, as the rules go farther than the prior policies in specifying that those entities must make data accessible in a standardized electronic format that patients can easily access and share. That, in turn, may also allow public health agencies to gather better data on the safety and effectiveness of drugs or track the spread of diseases such as Covid-19.
“It’s a big deal,” said Kenneth Mandl, a Harvard professor who directs the Computational Health Informatics Program at Boston Children’s Hospital. “The appetite for interoperability and the appetite for moving medicine toward a data-driven enterprise has increased dramatically.”
A decade ago, Mandl helped to develop a standardized data-sharing framework known as SMART on FHIR (Fast Healthcare Interoperability Resources), an interface that allows data housed in different systems and formats to be seamlessly shared among health providers, and between providers and patients. The rule requires that those parties now use the SMART on FHIR framework to make the data available via smartphone, so that it can be exchanged with limited effort and expense.

While the rules seek to prevent information blocking, they do not entirely eliminate the ability of entities that now control the information to make it difficult to access. For example, electronic health record vendors can still charge fees to app developers to gain access to information housed in their systems. Depending on the circumstances, those costs can be prohibitive, scuttling access to the data and efforts to make use of it for novel products and services.
Verma told STAT, however, that health care organizations will no longer have an ability to throw up such barriers to patients, who will be free to share it with whomever they want.
“Patients can donate their data to science,” she said. “Imagine what that looks like if innovators and researchers have the ability to analyze all of your data.”
Currently, hospitals are giving large technology companies access to patient data through private contracts that enable the development of new software products. But those arrangements are being made without disclosure to patients or the broader public, leaving people in the dark about how their information is being used.
Verma said those transactions are enabled by general consent forms most patients sign when they get care and that the new rules will make it easier for patients to control their data and become educated about efforts to leverage it for commercial purposes.
“It’s always been a focus of this administration to empower consumers with the information that they need,” she said, adding that patients will be able to consent to specific uses of the data when they share it. “It’s one of the things we’ve done in [Medicare] to train app developers on the front end to make sure they have plain language around their privacy and security practices in what they share with patients.”

New Trump rules aim to fuel sharing of patient health records by smartphone