21st Century Cures Act Could Have Big Tech Impact

Ken Terry

December 05, 2016

The 21st Century Cures Act, which the US House of Representatives adopted by an overwhelming vote last week and which is expected to pass the Senate and be signed by President Obama, has major implications for the future of health information technology. Not only does the legislation take a strong stand against "information blocking" by electronic health record (EHR) vendors and healthcare providers, but it also mandates the use of new methods of exchanging data between disparate EHRs.

Within 1 year after the bill's passage, the US Department of Health and Human Services (HHS) will have to require EHR developers to attest, as a condition of product certification, that they have not and will not engage in information blocking. The measure defines information blocking as practices that restrict authorized access, exchange, or use of information for treatment and other permitted purposes.

The HHS Office of Inspector General will be responsible for enforcing the prohibition against information blocking. Beyond the threat of decertification, "developers, networks and exchanges" found guilty of these practices will be fined up to $1 million per violation.

Provider organizations that block information exchange will not be fined. They will be "subject to appropriate disincentives" under applicable federal law, the bill says.

If an EHR is decertified because of information blocking, HHS can exempt for 1 year doctors and hospitals that have that EHR from payment adjustments under the Meaningful Use EHR incentive program or the Merit-Based Incentive Payment System (MIPS).

In response to a congressional request, the Office of the National Coordinator for Health IT (ONC) released a report on information blocking in April 2015. The report found credible evidence that some health information technology (IT) vendors and providers had erected barriers to the free flow of information between entities that used different EHRs. The language in the 21st Century Cures bill mirrors that in the ONC report.

Overall, the legislation aims to promote interoperability among disparate EHRs. To achieve this goal, the measure requires the use of application programming interfaces (APIs) to allow the exchange of data between different kinds of systems. Developers must publish APIs and allow "health information from such technology to be accessed, exchanged, and used without special effort through the use of APIs or successor technology or standards." They must also test the "real world use" of this technology for interoperability.

Once again, these new conditions of certification must be imposed on EHR vendors within a year after the bill's passage. However, the use of APIs for interoperability has not yet been tested. One technology that could be used for that purpose is based on a draft HL7 standards framework known as Fast Healthcare Interoperability Resources (FHIR). About 30 FHIR-based apps are already available, but most of them are designed for clinical decision support, not interoperability.

Two leading EHR vendors, Epic and Cerner, are working with outside developers to create FHIR-based apps. They and other EHR vendors are also involved in the Argonaut Project, an HL7-based consortium that is accelerating FHIR development. But it is unclear how health IT developers will be able to comply with this portion of the 21st Century Cures Act if the measure passes.

The bill also instructs ONC to work with the National Institute of Standards and Technology and other federal agencies to ensure "full network to network exchange of health information." Among other things, ONC is supposed to convene public-private partnerships to develop and support a trusted exchange framework within 6 months of the bill's passage. This framework and a related common agreement will include a method of user authentication, rules for trusted exchange, and policies to enable data exchange.

ONC will be required to pilot the exchange framework and agreement within a year and to publish a list of participating networks within 2 years.

All of this sounds very similar to the government's Nationwide Health Information Network (NwHIN), which was transferred to the private sector several years ago. NwHIN largely failed to improve interoperability, partly because private companies did not want the government telling them what to do.

The measure also includes a few other health IT-related provisions, as follows:

  • HHS is to encourage partnerships among healthcare stakeholders to promote the access of patients to their health information in a single, longitudinal format. ONC may also require this through EHR certification.

  • The Comptroller General is tasked with reviewing the policies of ONC and healthcare stakeholders to determine whether ONC can take further steps to improve patient matching.

  • Providers are allowed to use scribes in documenting patient encounters.

  • The US Food and Drug Administration (FDA) is barred from regulating mobile health apps designed to maintain or encourage a healthy lifestyle if those are unrelated to the diagnosis, prevention, or treatment of disease.

  • The FDA can't regulate EHRs or software that stores, displays, or transfers lab data. But it can regulate software that interprets or analyzes the data.

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