How should we react to 1,718 pages of new regulation? Let’s start by stipulating the White House and HHS perspective:
“Taken together, these reforms will deliver on the promise to put patients at their center of their own health care — you are empowered with control over your own health care choices.”
Next, let’s stipulate the patient perspective via this video lovingly assembled by e-Patient Dave, Morgan Gleason, and the folks at the Society for Participatory Medicine. In less than 3 minutes, there are 15 patient stories, each with a slightly different take on success.
The rather esoteric issue of a national patient identifier has come to light as a difference between two major heath care bills making their way through the House and the Senate.
The bills are linked to outrage over surprise medical bills but they have major implications over how the underlying health care costs will be controlled through competitive insurance and regulatory price-setting schemes. This Brookings comment to the Senate HELP Committee bill summarizes some of the issues.
Those in favor of a national patient identifier are mostly hospitals and data brokers, along with their suppliers. More support is discussed here. The opposition is mostly on the basis of privacyand libertarian perspective. A more general opposition discussion of the Senate bill is here.
Although obscure, national patient identifier standards can help clarify the role of government in the debate over how to reduce the unusual health care costs and disparities in the U.S. system. What follows is a brief analysis of the complexities of patient identifiers and their role relative to health records and health policy.
TEFCA will succeed where previous national health information exchange efforts have failed only if it puts patients’ and families’, and/or their fiduciary agents, in control of health technology. This is the only path to restore trust in physicians, and to ensure accurate and complete data for treatment and research.
As physicians and patient advocates, we seek a longitudinal health record, patient-centered in the sense of being independent of any particular institution. An independent health record is also essential to enhancing competition and innovation for health services. TEFCA Draft 2 is the latest in a decade of starts down the path to an independent longitudinal health record, but it still fails to deal with the problems of consent, patient matching, and regulatory capture essential for a national-scale network. Our comments on regulatory capture will be filed separately.
We strongly support the importance in Draft 2 of Open APIs, Push, and a relationship locator service. We also strongly support expanding the scope to a wider range of data sources, beyond just HIPAA covered entities in order to better serve the real-world needs of patients and families.
However, Draft 2 still includes design practices such as the lack of patient transparency, lack of informed consent, and a core design based on involuntary surveillance. This institution-centered design barely works at a community level and leaves out many key real-world participants. It is wishful thinking to believe that it will work with expanded participant scope and on a national scale.
The original sin of health records interoperability was the loss of consent in HIPAA. In 2000, when HIPAA (Health Insurance Portability and Accountability Act) first became law, the Internet was hardly a thing in healthcare. The Nationwide Health Information Network (NHIN) was not a thing until 2004. 2009 brought us the HITECH Act and Meaningful Use and 2016 brought the 21st Century Cures Act with “information blocking” as clear evidence of bipartisan frustration. Cures, in 2018, begat TEFCA, the draft Trusted Exchange Framework and Common Agreement. The next update to the draft TEFCA is expected before 2019 which is also the year that Meaningful Use Stage 3 goes into effect.
Over nearly two decades of intense computing growth, the one thing that has remained constant in healthcare interoperability is a strategy built on keeping patient consent out of the solution space. The 2018 TEFCA draft is still designed around HIPAA and ongoing legislative activity in Washington seeks further erosion of patient consent through the elimination of the 42CFR Part 2 protections that currently apply to sensitive health data like behavioral health.
The futility of patient matching without consent parallels the futility of large-scale interoperability without consent. The lack of progress in patient matching was most recently chronicled by Pew through a survey and a Pew-funded RAND report. The Pew survey was extensive and the references cite the significant prior efforts including a 100-expert review by ONC in 2014 and the $1 million CHIME challenge in 2017 that was suspended – clear evidence of futility.
In this edition of Health in 2 point 00, Jessica DaMassa asks me about enterprise sales (Qventus, Medicity, Health Catalyst), DTC vs Enterprises as a market, the VA allowing nationwide telehealth,, and the TEAP & TEFCA frameworks (that last answer may have overran the 2 minutes a tad!) — Matthew Holt