New Federal Data Rules Aim to Give Patients Control of Their Health Records

The Department of Health and Human Services (HHS) released groundbreaking rules that will let patients download their electronic health records and other health care data onto their smartphones. “Patients should have control of their records, period. Now that’s becoming a reality,” said Health and Human Services Secretary Alex Azar. “These rules are the start of a new chapter in how patients experience American health care.”  Officials said the rules likely will give patients a greater say in health care decisions and put an end to a long-standing practice in which some doctors and hospitals resist handing complete medical files over to patients upon demand.

The ONC final rule:

  • Establishes new rules to prevent “information blocking” practices (e.g., anti-competitive behaviors) by healthcare providers, developers of certified health IT, health information exchanges and health information networks.
  • Requires electronic health records to provide standardized, core data elements through the U.S. Core Data for Interoperability (USCDI) such as clinical notes, allergies and medications, to help improve the flow of electronic health information and ensure that the information can be effectively understood when it is received.
  • Establishes secure, standards-based application programming interface (API) requirements to support a patient’s access and control of their electronic health information.

The CMS Interoperability and Patient Access final rule:

  • Requires health plans in Medicare Advantage, Medicaid, CHIP and through the federal Exchanges to share claims data electronically with patients effective Jan. 1, 2021.
  • Requires that patients must be able to access their medical records on a smartphone at no cost and share those records as they choose.
  • Requires insurers to advise patients of their network of health providers through an app effective Jan. 1, 2021.
  • Establishes a new Condition of Participation (CoP) for all Medicare and Medicaid participating hospitals, requiring them to send electronic notifications to another healthcare facility or community provider or practitioner when a patient is admitted, discharged or transferred.
  • Requires states to send enrollee data daily beginning April 1, 2022 for beneficiaries enrolled in both Medicare and Medicaid, improving the coordination of care for this population.

Many of the provisions are set to take effect in 2022. While some are applauding the new rules, others have raised concerns about privacy as technology companies, such as Google, Microsoft, Apple and Amazon, open up new markets for providing medical records through mobile apps.

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