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ONC Proposed Rule Identifies Exceptions to Information Blocking

After a long delay, an ONC rule on information blocking is making its way to the Federal Register.

Health data exchange, information blocking

Source: Thinkstock

By Kyle Murphy, PhD

- The Office of the National Coordinator for Health Information Technology (ONC)has ushered in the next phase of the 21st Century Cures Act with the impending release of a proposed rule on interoperability and information blocking.

“By supporting secure access of electronic health information and strongly discouraging information blocking, the proposed rule supports the bi-partisan 21st Century Cures Act,” stated National Coordinator Don Rucker, MD. “The rule would support patients accessing and sharing their electronic health information, while giving them the tools to shop for and coordinate their own health care.”

Primarily, ONC will be holding health IT developers accountable as a condition of certification. However, another proposed rule — one to be published by the Centers for Medicare & Medicaid Services (CMS) — will extend accountability to Medicare, Medicaid, and CHIP providers.

“For far too long, electronic health information has been stuck in silos and inaccessible for healthcare consumers. Our proposals help break down existing barriers to important data exchange needed to empower patients by giving them access to their health data,” announced CMS Administrator Seema Verma.

Together, both offices within the Department of Health & Human Services (HHS) will provide public reports of information blocking practices that limit interoperability and health data exchange.

“We believe it would benefit patients and caregivers to know if individual clinicians, hospitals, and critical access hospitals (CAHs) have submitted a ‘no’ response to any of the three attestation statements regarding the prevention of information blocking in the Promoting Interoperability Programs,” CMS officials explained. HHS Proposed Rules Detail Conditions of Information Blocking

In its proposed rule, ONC drew attention to the authority of the Office of the Inspector General (OIG) to issue civil money penalties for information blocking as well as “investigate health care providers for information blocking for which health care providers could be subject to disincentives.”

An important component of the proposed rule is the list of proposed exceptions to information blocking that assist in defining the practice. The federal agency identified seven:

  • Engaging in practices to prevent patient harm
  • Engaging in consistent, non-discriminatory practices to protect the privacy of electronic health information
  • Implementing practices to promote the security of electronic health information
  • Performing maintenance or improvements to health IT performance with the agreement of the user
  • Recovering reasonable costs to allow for the access, exchange, and use of electronic health information
  • Receiving a request to provide access, exchange, or use of electronic health information that is infeasible because the request would impose a substantial burden that is unreasonable under the circumstances
  • Allowing for the licensing of technical artifacts to support the interoperability of EHI on reasonable and non-discriminatory terms

As ONC officials explained, three principles guided its decision-making:

First, the exceptions would be limited to certain activities that clearly advance the aims of the information blocking provision; promoting public confidence in health IT infrastructure by supporting the privacy and security of EHI, and protecting patient safety; and promoting competition and innovation in health IT and its use to provide health care services to consumers. Second, each exception is intended to address a significant risk that regulated individuals and entities (i.e., health care providers, health IT developers of certified health IT, health information networks, and health information exchanges) will not engage in these reasonable and necessary activities because of potential uncertainty regarding whether they would be considered information blocking. Third, and last, each exception is intended to be tailored, through appropriate conditions, so that it is limited to the reasonable and necessary activities that it is designed to exempt.

Healthcare application programming interfaces are to play a critical role in enabling data access and exchange in the two proposed rules, with the CMS rule largely working to support the MyHealthEDATA and its patient data access goals.

The ONC rule looks to promote the adoption of APIs, namely Fast Healthcare Interoperability Resources (FHIR), whereas the CMS rule will hold qualified health plans accountable for using FHIR-based APIs to give patients timely access to claims data.

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