The Department of Health and Human Services (HHS) recently issued proposed regulations that could enhance the value of electronic health information. Specifically, the proposed regulations focus on the areas of interoperability and patients’ access to their health data.
Electronic health information is a relatively new phenomenon. It became a subject of national importance in 2004, when President George W. Bush announced a plan to computerize most Americans’ health records by 2014. The transition to electronic health records (EHRs) accelerated under President Barack Obama who passed the Health Information Technology for Economic and Clinical Health (HITECH) Act as part of the 2009 stimulus plan, the American Recovery and Reinvestment Act. The HITECH Act dedicated $19 billion to promoting the adoption of health information technology. Eligible professionals and hospitals received substantial incentive payments through Medicare and Medicaid for implementing certified EHR systems. Now EHR systems are nearly ubiquitous in medical offices.
HHS began regulating the quality and use of EHR systems in 2011. It has done so by implementing Meaningful Use and Certification regulations. As I have argued in my book, Electronic Health Records and Medical Big Data: Law and Policy, these regulations have many benefits but also significant shortcomings. HHS is now attempting to address some of these limitations.
Seemingly insurmountable barriers to full interoperability have been a major disappointment in the electronic health information arena. Interoperability is “the ability of different information systems, devices or applications to connect, in a coordinated manner, within and across organizational boundaries to access, exchange and cooperatively use data.” Policy-makers have long hoped to build a nationwide, interoperable health information technology infrastructure, but they acknowledge that we have fallen far short of meeting this goal.
Currently, EHRs in one health system all too often remain inaccessible to physicians in other health systems. Thus, patients’ EHRs are fragmented, with pieces of them housed in different facilities. When a patient goes to a doctor for a second opinion or specialized care, the new doctor cannot necessarily access the patient’s EHR at other facilities to obtain the patient’s full medical history, diagnoses, test results, and other information. Similarly, physicians in hospital emergency rooms may not be able to access patient records and could be forced to provide treatment with little to no information about the individual’s health status if the person arrives unconscious or confused. Comprehensive, national interoperability would allow physicians with proper authorization to retrieve patients’ records anywhere in the country in any medical entity.
Interoperability would yield other benefits as well. It would enable health care providers to switch more easily to new EHR systems if they are dissatisfied with the products they have. This is because clinicians could easily transition all patient records to a new system. Technological innovations could also have much faster uptake because they could sync with all EHR systems.
Not surprisingly, EHR vendors often are not highly motivated to promote interoperability because it could increase the likelihood that established customers will switch to different systems. Likewise, some health care organizations may not be enthusiastic about sharing patient information with competitors. Consequently, interoperability will not happen without aggressive regulatory intervention.
Another way to promote interoperability is to empower patients to obtain and share their health information. The HIPAA Privacy Rule establishes that patients have a right to access, inspect, and obtain copies of their health information that HIPAA-covered entities maintain. Covered entities include health care providers, public and private health plans, health care clearinghouses, and their business associates. If patients can easily obtain their medical data, they could presumably provide it directly to other physicians and facilities that they visit.
Patients also have a right to ask covered entities to modify their health information if they believe it is inaccurate. Patients who access their health data thereby can contribute an important layer of quality control to medical record-keeping. EHRs are all too often rife with errors. It is patients themselves who may be in the best position to scrutinize documentation and detect mistakes.
The proposed regulations in part would establish the following requirements:
- Certain covered entities, namely Medicaid, the Children’s Health Insurance Program, Medicare Advantage plans, and Qualified Health Plans in the Federally-facilitated Exchanges, must provide enrollees with immediate electronic access to claims data and other health information by 2020;
- These covered entities must implement technologies (application programming interfaces) that promote data sharing so that patients can more easily transition between plan types;
- Patients must be able to access their data electronically at no cost;
- Health care professionals or hospitals that engage in “information blocking” activities that unjustifiably limit data access and hinder interoperability will be subject to public reporting of their misconduct.
HHS is accepting comments on the proposed regulations until April 2019. It will likely modify the rules later this year to address various concerns that commentators raise. In whatever form they ultimately take, the new regulations certainly will not fully solve the problem of interoperability. For example, the electronic data access provisions outlined above will govern particular health insurers and not health care providers and will apply to 125 million patients rather than all Americans. However, the regulations may well promote meaningful incremental advances and reinforce policy-makers commitment to the ultimate goal of national interoperability.
Sharona Hoffman is the Edgar A. Hahn Professor of Law, Professor of Bioethics, and Co-Director of the Law-Medicine Center at Case Western Reserve University School of Law. She holds a B.A. from Wellesley College, a J.D. from Harvard Law School, an LL.M. in health law from the University of Houston, and an S.J.D in health law from Case Western Reserve University. Dr. Hoffman has written over 50 substantial articles and book chapters and dozens of shorter pieces on health law and civil rights topics. She is also the author of two books: Aging with a Plan: How a Little Thought Today Can Vastly Improve Your Tomorrow and Electronic Health Records and Medical Big Data: Law and Policy. She was elected to membership in the American Law Institute in 2017.
Suggested Citation: Sharona Hoffman, Access to Health Records: New Rules Another Step in the Right Direction, JURIST – Academic Commentary, February 20, 2019, http://www.jurist.org/commentary/2019/02/sharona-hoffman-health-records-proposal/
This article was prepared for publication by Stephanie Sundier, a JURIST Staff Editor. Please direct any questions or comments to her at firstname.lastname@example.org