Empowering American Patients with Access and Control over their Healthcare Data

You have a right to your healthcare information. This fundamental principle has long been enshrined in American healthcare policy, serving as a core component of HIPAA, the HITECH Act, and the 21st Century Cures Act. Unfortunately, far too many American patients find it difficult—if not outright impossible—to fully exercise that right. Despite incredible technological advances, driven by the hard work of a generation of reformers and entrepreneurs, patients still experience the unnecessary delays and clinical risks created by the lack of access to their own healthcare information.

That changes today.

Earlier today, the Trump Administration announced the release of two groundbreaking regulations from the Department of Health and Human Services (HHS)—the Centers for Medicare & Medicaid Services (CMS) Interoperability and Patient Access final rule and the Office of the National Coordinator for Health Information Technology (ONC) 21st Century Cures Act final rule.

Together, these rules ensure patients have access to and control of their own health records, empowering Americans to view their entire record when they want, how they want, and where they want. Patients will be able to securely share their record with family members and the doctors, hospitals, and plans of their choice. They will have greater ability to see the cost of their care, choose the doctor that is right for them, and receive treatments more tailored to their needs.

Through the ONC rule, HHS has finalized Health Level 7 (HL7®) Fast Healthcare Interoperability Resources (FHIR®) Release 4.0.1 as the foundational standard for data exchange. It supports the use of application programming interfaces (APIs) as part of the Certified Electronic Health Record Technology program promoting the widespread use of this important technology. Once the policies in this final rule are implemented, patients will be able to access key medical information from their doctor’s electronic health record using their smartphones. The Administration has listened diligently to the widespread public comments on this important issue and we look forward to continuing to work with all stakeholders on these reforms.

CMS, through their final rule, is ensuring that all CMS-regulated payers—including those in Medicare Advantage, Medicaid, CHIP, and Qualified Health Plans (QHPs) on the Federally facilitated exchanges—make patient claims and encounter data available through the Patient Access API. Giving patients their health information when and how they need it most will empower them to be better decision makers and informed partners in their healthcare. It will allow for more coordinated, higher quality, and more cost-effective care that could lead to better health outcomes.

Starting January 1, 2021, you can request that your insurer provides you with secure access to your health information via the Patient Access API. This is a watershed development for America’s healthcare system that will unleash the next generation of healthcare innovation, enabling developers to competitively build new apps and services that will provide you with improved ways to guide your own healthcare choices.

One major impact of these rules is that millions of American patients will have prompt and secure access to their medical records with the touch of a button. Consider what this will do for those who find travel difficult or live in rural areas where access to care can vary widely. Rural patients will be able to hold their health information in the palm of their hand, significantly simplifying the logistics of their care.

Over the past three years, at the White House and across the country, we have listened to American innovators, clinicians, researchers and patients; we have heard you loud and clear. It should not be difficult for patients to access their records or coordinate their own healthcare choices. Clinicians, after years of intensive medical education, should be spending more time with patients; they should not be spending long hours on their nights and weekends catching up with clerical burdens. Today’s reforms prioritize patients over paperwork, empowering all healthcare stakeholders to focus more on what matters—improving the quality of healthcare outcomes for all patients at lower cost.

We must also remember the importance of maintaining the privacy and security of this sensitive information. All stakeholders have a responsibility to patients to help them make well-informed choices about how to use and share their information. That is why HHS is taking additional steps to provide doctors, hospitals, payers and patients opportunities and information to protect patient data. As part of the ONC and CMS final rules, a provider or payer may ask third-party app developers to attest to certain privacy provisions, such as whether or not their privacy policy specifies all possible secondary data uses, and inform patients about these attestations. HHS is also working with providers and payers to provide information they can use to educate patients about sharing health information with third parties, and about the role of Federal partners like the HHS Office for Civil Rights and the Federal Trade Commission in protecting their rights.

In the best traditions of our country, this important work has unified a diverse array of stakeholders who do not always agree, yet who stand together in strong support of these important reforms. The Trump Administration is dedicated to ensuring patients have access to the information they need, when they need it, and in a format they can truly understand and use. Today’s reforms represent a significant step forward that will open up new frontiers of medical innovation, and could ultimately improve the quality of your healthcare and lower your costs.

The Trump Administration looks forward to working with all stakeholders on this important work going forward.

For more information about the final rules, please visit:

ONC Final Rule & Fact Sheet

CMS Fact Sheet

CMS Final Rule

HHS Press Release