ABSTRACT
Under the 21st Century Cures Act and the Office of the National Coordinator for Health Information Technology (ONC) rule implementing its interoperability provisions, a patient's rights to easily request and obtain digital access to portions of their medical records are now supported by both technology and policy. Data, once directed by a patient to leave a Health Insurance Portability and Accountability Act-covered health entity and enter a consumer app, will usually fall under Federal Trade Commission oversight. Because the statutory authority of the ONC does not extend to health data protection, there is not yet regulation to specifically address privacy protections for consumer apps. A technologically feasible workflow that could be widely adopted and permissible under ONC's rule, involves using the SMART on FHIR OAuth authorization routine to present standardized information about app behavior. This approach would not bias the patient in a way that triggers penalties under information blocking provisions of the rule.
Subject(s)
Confidentiality/legislation & jurisprudence , Electronic Health Records/legislation & jurisprudence , Software/legislation & jurisprudence , United States Federal Trade Commission , Consumer Product Safety , Humans , Odds Ratio , Privacy/legislation & jurisprudence , United StatesABSTRACT
The 21st Century Cures Act requires that certified health information technology have an application programming interface (API) giving access to all data elements of a patient's electronic health record, "without special effort". In the spring of 2020, the Office of the National Coordinator of Health Information Technology (ONC) published a rule-21st Century Cures Act Interoperability, Information Blocking, and the ONC Health IT Certification Program-regulating the API requirement along with protections against information blocking. The rule specifies the SMART/HL7 FHIR Bulk Data Access API, which enables access to patient-level data across a patient population, supporting myriad use cases across healthcare, research, and public health ecosystems. The API enables "push button population health" in that core data elements can readily and standardly be extracted from electronic health records, enabling local, regional, and national-scale data-driven innovation.
ABSTRACT
A patient-centered health system needs precise computable measurements to derive value. While validated patient-reported outcomes (PROs) are increasingly used in trials, their adoption in care remains limited and generally separated from the medical record. Further, absence of systematic processes for patient-led data submission excludes valuable data from digital devices that can potentially aid in contextualizing health status. With prior experience in developing apps for the Patient-Reported Outcomes Measurement Information System (PROMIS), we sought to make collecting patient-generated health data (PGHD) a fundamental property of health information technology at scale, and in an interoperable, standards-compliant fashion. We build upon the open SMART on FHIR (Fast Health Interoperability Resources) specification to create SMART Markers-a mobile device software framework encapsulating functionality needed for rapid deployment of both patient- and practitioner-facing PGHD apps. We refactored previously developed PROMIS apps to use SMART Markers for handling PGHD-request creation, on-device administration, and generation of a variety of PGHD types and submission of results to a FHIR server. Validation and conformance tests were performed on the generated output and app-reusability was demonstrated across two demo servers. App developers can import SMART Markers into their existing or new apps to readily leverage an interoperable PGHD capturing functionality out of the box, without having to reinvent the wheel. Our approach enables the creation of health system integrated, context-specific experiences for both patients and practitioners.