21st Century Cures is now law. Aside from its touted research and mental health provisions, it’s the most significant health information technology regulation since HITECH, now 8 years ago. A decent summary of the health IT provisions of the bill by John Halamka concludes with “That is just not realistic.” He’s almost certainly right to the extent your perspective is the hospital-centered mega-EHR model. You can’t get there from here.
Halamka and others who think that consolidated institutions will drive interoperability are in denial of the gap between financial integration and clinical integration. This recent post by Kip Sullivan describes some of the wishful thinking. But there’s another reason why HITECH’s institutional EHRs cannot get us to the Triple Aim, and it’s mostly about liability.
Halamka ignored one of the items in 21st Century Cures that could lead to clinical integration around a patient: a longitudinal health record. Section 4006 on page 149 includes:
“(1) IN GENERAL.—The Secretary shall use existing authorities to encourage partnerships between health information exchange organizations and networks and health care providers, health plans, and other appropriate entities with the goal of offering patients access to their electronic health information in a single, longitudinal format that is easy to understand, secure, and may be updated automatically.”
Useful longitudinal health records require curation and, almost by definition, the curators are not going to be affiliated with any single hospital or other institution operating a traditional EHR. Allowing licensed physicians, family caregivers, and the patient themselves to edit an institutional EHR is risky to the point of impossible. That’s why the current initiatives to introduce modern APIs into EHRs like SMART and Sync for Science are read-only.
No institution can afford the liability of unaffiliated outsiders editing their internal systems. That means that a curated, de-duplicated longitudinal health record has to be owned either by a government agency or the patient themselves. Centralized government health records in many European nations are not a panacea and unlikely in our privatized US system. The bureaucracy to govern them is almost as stifling as Meaningful Use. That leaves patient-centered longitudinal health records.
A patient-centered health record is not a free-for-all. The liability in curating the patient-centered EHR rests with the licensed practitioners, primarily physicians, that are allowed by that patient to touch them and edit their EHR. Physicians a paid to assume that risk and have a deep professional incentive to put their duty to the patient ahead of any institutional employment relationship. This is why clinical health IT will eventually shift to support of the physician-patient relationship. Eventually.
21st Century Cures, like HITECH at the dawn of the Democrat administration, is just a law. It will be up to the Republicans to reverse the regulatory capture that has made today’s EHRs a source of frustration for both physicians and patients and an albatross around the neck of health reform. HIPAA, HITECH, and Cures are all fully consistent with patient-centered EHRs. But interoperability projects like HEART are still at a fork between trust rooted in institutions and trust rooted in individual physicians and patients. My state medical society in Massachusetts is also realizing the importance of shifting the root of trust in health IT away from hospitals and back to the licensed physician. What’s missing is a market for patient-centered health records.
Who will make the market for patient-centered health records? Will sophisticated outsiders like Salesforce and IBM grow new consumer-facing brands to serve the physicians and patients as customers? Will Apple broaden its leading consumer privacy brand to include life-and-death and regulated clinical applications? Will HIMSS start a showcase for health IT that physicians or patients can actually buy for themselves? Is true decentralization based on blockchain technology the future of a sovereign physician-patient relationship?
I’m betting on the latter but I think all of the above will play a significant role – if the Trump administration reverses the regulatory capture legacy of HITECH.