In December 2016, the 21st Century Cures Act was signed into law with significant bipartisan support. The act allocates nearly $5 billion to the National Institutes of Health (NIH) to advance the Precision Medicine Initiative and support former Vice President Biden's "cancer moonshot," but also contains several provisions that will directly impact digital health.
While the legislation will be open to interpretation under President Trump's administration and the 115th Congress, history suggests that the new Secretary of the Department of Health and Human Services (HHS) will not favor burdensome regulation, especially regulations that place a burden on clinicians.
Political uncertainties aside, interoperability remains an industry priority. Having actionable patient intelligence available at all critical points of care allows clinicians to make optimal decisions, which can result in cost savings, better care quality, and improved safety.
As clinicians and technology providers continue to digest the details of the law's 996 pages, below are some of its key health IT provisions:
Electronic health record (EHR) incentives
EHR Meaningful Use incentives will be prioritized, focusing on activities that improve patient care and the clinical documentation process.
Meaningful Use reporting
Meaningful Use program attestation statistics, including information by state and the number of providers who did not attest, will be available to the public by the HIT Advisory Committee.
Health IT for specialties and sites of service
Concerted efforts will be made to encourage voluntary certification for medical specialties and sites of service for which technology is not available.
Information blocking and reporting transparency
Health IT developers must prove that their solutions do not block health information exchange, while the Federal Trade Commission (FTC) and HHS must clearly define activities that do not constitute data blocking.
Interoperability
The Office of the National Coordinator for Health Information Technology (ONC) will establish a trusted exchange network created through public-private partnerships to improve interoperability. A provider digital contact information index for professionals and facilities will be created, and The HIT Advisory Committee will replace the current Policy and Standards Committees.
Standards adoption
HHS will address priority uses of HIT arising from the implementation of Merit-Based Payment Incentive Systems (MIPS), Alternative Payment Models (APMs) and Meaningful Use-related payment programs to advance standards adoption. It will also identify existing standards and implementation specs that support information exchange.
Registries and Patient Safety Organizations (PSOs)
EHR vendors will be treated as providers for reporting purposes, conducting activities related to patient safety, care quality and outcomes to help improve patient safety. EHRs must also be able to transmit, receive and accept data from registries, including clinician-led data registries.
Patient data access and patient empowerment
Partnerships among health information exchange (HIE) networks, health plans and providers are encouraged to give patients better access to their records in a single, electronic format. Specifically, the EHR vendor certification process will support better patient data access. The HIT Advisory Committee will focus on standards and certification criteria that support data access and usability.
Government Accountability Office (GAO) studies
The GAO will conduct multiple studies designed to improve patient identification matching and overcome barriers related to patient data access, such as fees for record requests or transfers and issues related to the form and format of requests.
The 21st Century Cures Act has significant industrywide implications, and 2017 will be a year of continued transformation and transition. For all who touch the digital health landscape, it's important to remember that healthcare interoperability is not far off in the horizon, but is achievable and happening right now. Health information exchange isn't just about moving data around—it's about sharing data with all parties. In doing so, our healthcare system can truly leverage a wealth of information that has the capacity to improve care for all.
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