During comments delivered at the 2016 ONC Annual Meeting, AMIA President & CEO Douglas B. Fridsma, MD, PhD, FACP, FACMI, called on public and private stakeholders to provide patients with total access to their complete electronic health data. The following statement was released today in conjunction with Dr. Fridsma’s appearance.
Access to information and the ability to integrate and use information has changed how individuals book travel, find information about prices and products, and compare and review services. Information can empower individuals, but health care has lagged behind other fields. It is unconscionable that in 2016 most patients are unable to obtain their entire medical record unless they print it out.
While progress has been made in the last several years to support patients’ access to their information through various electronic means, such as Blue Button and patient portals, this is not sufficient to make patients first-order participants in their care, their health and their research efforts. Patients deserve nothing less than total access to their complete electronic health data.
Modifications to HIPAA through HITECH set the foundational expectation that patients have a right to an electronic copy of their health information. Guidance from OCR clarifying this right in terms of form, format and manner of access is another important step forward. Yet, the operationalization of these policies has only rendered slivers of information available for patients to use as they see fit. Patients have a right to all of their health information, not just what CMS defines through meaningful use, or what ONC’s certification program deems necessary to meet CMS’s definition.
AMIA believes if the information is stored electronically, patients are entitled to their entire medical record in an electronic format, and not just a summary record or the limited data that a vendor chooses to make available via portal or API. Patients deserve more than PDFs, and the benefits of digitizing healthcare will only be realized when patients – and providers – have fluid, portable data. By developing a functionality as simple as “print all,” we will empower patients to more fully participate in their care by spurring an ecosystem of wellness and mHealth apps; we will improve the quality and frequency of participation in precision medicine, and other kinds of research; and we will foster a data-driven feedback loop between patients and their providers.
We commend federal efforts to improve access, such as recent guidance from the HHS Office of Civil Rights, as well as initiatives to educate providers and patients on the rights afforded by HIPAA. But until we develop the electronic equivalent of “print all” for patients, which goes beyond PDFs and summary records, we will continue our struggle to free patient data. APIs may provide improved access over portals, but they carry forward the fundamental paradigm of closed systems with a predetermined notion of which data the patient should access.
Today, we call on the federal government to enable patients to have total control of their complete medical record by removing a prohibition found in certification that restricts the use of unstructured data, 1 and we call on CMS and OCR to use their levers so that such functionality is broadly available to every patient by 2018.
ONC must remove the prohibition on the “unstructured document” document-level template and require certified health IT to enable patients to have a full extract of their health data. The prohibition – originally included to prevent unstructured data overload – has outlived its usefulness. Further, this prohibition has muted conversations on data portability for providers looking to switch EHRs, who currently only have access to summary records of their patients’ data. Removing the prohibition and allowing use of the entire suite of CDA templates is aligned with FHIR-based resources to support multiple modes of exchange. Convergence is not only possible, it’s likely, given the direction of standards development.
Multiple policies and agencies have converged to improve patients’ ability to be first-order participants in their care. The federal government has played a vital role and the final piece is to enable patients to have complete access to a “full extract” of their health data.
1 45 CFR § 170.205 - § 170.205 Content exchange standards and implementation specifications for exchanging electronic health information. The Secretary adopts the following content exchange standards and associated implementation specifications: (a) (3) Standard. HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, (incorporated by reference in § 170.299). The use of the “unstructured document” document-level template is prohibited.