Draft rules on health information: a ‘Reformation’ in the making?

The hot-button issues in health care today are high drug prices, surprise medical bills, and “Medicare for All.” So it’s no surprise that recent draft rules on health information technology that could profoundly alter the landscape of American medicine have received little attention.

These draft regulations, swaddled in hundreds of pages of technical language, decisively disrupt medicine’s clinical and economic power structure by removing control over digitized health information from institutions and giving it to patients.

Think of it as a health care version of the Protestant Reformation, a societal upheaval propelled by suddenly making information once confined to the priesthood available to everyone.

The regulations are set out in complementary rules from the Office of the National Coordinator for Health Information Technology and the Centers for Medicare and Medicaid Services. Together, they implement the ban on “information blocking” contained in the bipartisan 21st Century Cures Act. In simplest terms, providers and other groups that now control electronic health record information must share it if a patient directs them to do so.

Just as the Reformation opened the way to religious pluralism, the demise of information blocking is expected to make health care innovation geared to individuals blossom. Instead of consumers being locked into a particular local health care delivery network, they will be able to direct their health information to a different doctor across town or, for that matter, use it to seek health advice of any kind anywhere in the world. That advice may come from individuals, but it will also be available from organizations that apply sophisticated analytics to detailed electronic health record data to assess an individual’s likely outcomes of treatment based on other “patients like me.”

Just as the Reformation didn’t eliminate the need for clergy, we’ll still need doctors, hospitals, and health plans. Moreover, massive cultural change doesn’t happen overnight. Still, the groups dominating health care today will inevitably face disruptive new challenges and challengers. Competition will intensify to provide cost-effective, measurably better care, generating new opportunities for collaborative relationships to maintain wellness and treat disease.

But before that can happen, pro-consumer and pro-competitive provisions must make it into the regulations’ final form. Right now, industry stakeholders realize what they might lose, while the public has remained largely oblivious to what it might gain.

For example, the draft rules mandate that providers give patients their information in a form readable by application program interfaces, or APIs, which provide the technical underpinning of apps. The goal is to make patient-directed health information exchange as secure, private, reliable, and easy as linking your bank account to pay bills. However, the details and time frame for making this happen are under dispute.

This patient-directed health information exchange differs dramatically from the institutional model that’s long dominated policy. To switch metaphors, imagine if you couldn’t have an independent mechanic plug into your car’s computer to see what’s wrong, and it could be done only at the dealership. Or if you could no longer keep your mobile number when changing phone companies.

Underlying all of these new rules is a determination to give patients a near-absolute right to have and control access to their lifetime digitized health records, including medical claims. Not surprisingly, moving to patient-directed health information exchange worries those who control the current delivery system. Information blocking by hospitals has trapped patients who’d like to take their information elsewhere, and limits doctors who might otherwise refer patients to better or more cost-effective lab, imaging, or treatment services.

Under the draft rules, any hospital that continues information blocking risks being expelled from Medicare — a provision that hospital groups strongly oppose.

Although the regulations directly affect only those in Medicaid, the Children’s Health Insurance Program, Medicare Advantage plans, and health plans in Affordable Care Act exchanges, that amounts to 125 million people. Other providers and insurers will be hard pressed to deny the same access.

As political realists, we understand that lobbying by industry groups could weaken the draft requirements or extend deadlines. The extent to which that will happen depends upon whether the public makes its voice heard and whether the administration holds firm on pushing health care into an Information Age era of cost and quality competition.

In the 16th century, the Reformation used the revolutionary power of the printing press to give people direct access to religious information. In the 21st century, the federal government must use the even greater power of the internet to give individuals the control over their health information they deserve.

Michael L. Millenson is a consultant, policy activist, adjunct faculty at the Northwestern University Feinberg School of Medicine, and author of “Demanding Medical Excellence: Doctors and Accountability in the Information Age.” Adrian Gropper, M.D., a pioneer in patient-controlled health care, is the chief technology officer of Patient Privacy Rights, a nonprofit that advocates for open health data.