Blog Post June 27, 2019 A Vision for Seamless Interoperability and Patient Insights Authors Fred Martin, III Asif Shah Mohammed Imagine a future in which patients have access to their aggregated longitudinal medical record from all available sources on their smartphone, and they continue to build that record over time. This future would be populated with not only information their providers document at the point of care, but also real-time insights from other determinants of health in their daily lives, including food and nutrition, sleep, exercise, mental state, education, and other environmental conditions that impact quality of life. In the same world, imagine providers receiving actionable insights on their patients without needing a fax machine or playing phone tag. They have tools that provide understanding of how well a patient is adhering to a new care plan in the weeks after an in-person visit and can provide meaningful guidance in a timely manner to drive patient behavior. In this reimagined future, vendors and provider organizations would collaborate to eliminate the data silos and other barriers to information sharing that are predominant across the health IT landscape. The 21st Century Cures Act: Complex Legislation with Simple Goals In the recently proposed US Department of Health and Human Services (HHS) rules on health data blocking and interoperability, CMS and the Office of the National Coordinator (ONC) for Health IT strive to be the catalyst for achieving this vision. The 21st Century Cures Act (passed in late 2016) was primarily billed to drive funding for precision medicine, adjusting drug development rules for pharmaceutical companies, tweaking Medicare reimbursement regulations, opening up opportunities for telehealth, and strengthening EHR certification protocols. It also includes information-blocking provisions, which has wide bipartisan policy consensus, with the proposed rules providing the framework for ONC’s implementation of the duties assigned in the legislation. Despite the complexity of the proposed rules (concisely summarized in this ONC fact sheet), the intentions and goals impacting patients and providers are simple: PatientsProvide effortless access to their personal electronic health information (EHI).Promote contribution to the medical record, from an ecosystem of preferred patient applications that aggregate information on determinants of health. Foster innovation and competition in the health IT space to promote the creation of applications and technology that utilize EHI from the EHR in meaningful ways for patients. Provide effortless access to more standardized and useful patient EHI from multiple sources.Deliver more actionable patient insights and complete information to inform clinical decisions. Providers Provide effortless access to more standardized and useful patient EHI from multiple sources.Deliver more actionable patient insights and complete information to inform clinical decisions. Require seamless interoperability between EHR systems by developing more stringent certification criteria for vendors and substantial penalties and disincentives for data-blocking practices by any healthcare stakeholder. Components of the proposed rules are described in figure 1. Stakeholders across Healthcare React Despite a clear focus on patients and providers, the proposed rules have major impacts on all stakeholders across healthcare, including EHR vendors, health IT innovators, payers, and health plans. The complexity of updated certification criteria for EHR vendors and the vague, yet severe, implications of data-blocking practices caused many industry groups like AHA and CHiME to demand additional clarity and a more gradual approach to the proposed rules’ implementation timeline. Despite the questioning and dissent expressed by industry stakeholders, ONC’s defense and support of the intentions of the rules have been unwavering. Donald Rucker, MD, the National Coordinator for Health IT, stated that “there are two goals: open up the data and EHRs to empower the patients and end information blocking. Modern APIs drive the whole smartphone economy, and this is missing in healthcare.” While the healthcare IT industry has offered the strongest reactions to the proposed rules, the creators of the rules appear to have taken a consumer-centric approach, keeping the patient top of mind. In a recent panel discussion with healthcare innovators in Boston, Dr. Rucker reiterated this focus: “When I talk about stakeholders, you need them because they all have a voice, but the biggest stakeholder is the American public.” Outlook and Next Steps While the commentary period deadline has passed, given expressed concerns and with thousands of public comments on the proposed rules, final rules with clear implementation steps and timelines may require additional iteration, interim rules, and feedback from stakeholders. This would include future rule making for developing the details of the associated penalties and disincentives for information blocking. Together, CMS and ONC’s proposed rules are designed to address the interoperability of health data and ultimately eliminate barriers to a provider’s and patient’s ability to access essential health information when and where it is needed. We anticipate that aligning requirements for the various industry players (payers, healthcare providers, and health IT developers) will lay the groundwork for establishing standards and driving innovation to ultimately benefit the patient (consumer).