ONC has proposed updates to the ONC Health IT Certification Program and the Information Blocking Rule. The proposals reflect an ongoing maturation of standards that developers of certified electronic health record (EHR) technologies and API technologies will be expected to meet. The proposal also reflects a clear policy priority to promote interoperability through the Trusted Exchange Framework and Common Agreement (TEFCA), under a proposed Information Blocking safe harbor.
September 1, 2023, marks a pivotal moment in health IT as the HHS begins enforcing penalties for information blocking. As part of these significant updates, it’s essential to recognize the implications and ensure you’re aligned with compliant vendors.
For context, this enforcement could lead to substantial fines — up to $1 million per violation. Those liable for these penalties include:
- Health IT developers of certified health IT
- Entities offering certified health IT
- Health information exchanges
- Health information networks
Other priorities reflected in the proposal have to do with public health reporting, algorithmic transparency in decision support tools (now called decision support interventions), health equity, and – significantly for b.well and its customers – a reaffirmation of the primacy of patient access and API-based interoperability.
For example, the proposed updates to the ONC Health IT Certification Program include significant operational enhancements for certified patient access APIs. ONC also proposes new semi-annual reporting obligations for electronic medical record (EMR) vendors, to help policymakers and industry learn which tools patients use to access their data, and the types of convenience features and capabilities available through these tools that might encourage them to access their data more.
ONC’s proposal includes RFIs covering topics that include FHIR-based scheduling APIs, real time benefit tools, lab test interoperability and SMART HealthLinks (QR Codes) to support exchange of authoritative information, following the standard that gained ground with digital COVID-19 vaccine credentials.
b.well is excited that ONC is doubling down on patient access and API-based interoperability as well as the level of detail in the ONC’s proposed “Insights Condition of Certification,” which lays out the new semi-annual reporting obligations. This proposal reveals a detailed understanding of consumer health digital tools – not just patient portals but provider-provisioned applications, health information networks, and true “third party applications”.
The reporting obligations would allow data-driven insights about the number of apps actively connected to patient access APIs, consumer usage of these apps, and the types of FHIR resources being consumed. The reporting has potential to reveal correlations between patient access and access to convenience features like scheduling, secure messaging, and prescription refill requests. This lines up with our long-held view about the power of the b.well platform to help our customers deliver a singular launching-off point for their consumers, where the ability to create a consolidated health summary will be rapidly combined with convenience features. This will help consumers access care for their families and make informed choices that make relevant, personalized prices, and coverage available in real time.
b.well interprets the ONC RFIs as a signal of ONC’s understanding of patient access as a starting point in the interoperability journey. Directing attention to convenience features like scheduling, real time benefit tools, and SMART HealthLinks is a sign that ONC is committed to the shoppable consumer experience in healthcare.
The ONC proposal also includes a potential safe harbor for TEFCA. TEFCA is not yet live, and much remains to be learned about the costs of transacting through TEFCA and the data rights some QHINs may require to build sustainable business models in document-based exchange using internet technologies (IHE and CCD-A) from the 1990s. While we are hopeful about TEFCA, we urge our customers to understand the fine print.
With TEFCA, there may be greater costs and a loss of control over data rights. In contrast, b.well aims to increase data access for consumers in a safe and secure way while committing to not sell data. These are examples of the considerations our customers need to think about, and which we think about, as the pricing and contractual terms of TEFCA QHINs become more transparent.
This proposal reinforces ONC’s commitment to FHIR API-based interoperability, patient access, consumer convenience features, and burden reduction through technology. ONC estimates the proposal’s costs at $742 billion over 10 years, with opportunities for an estimated $1 billion in annual savings. Industry organizations must evaluate how many of these costs are priced into their vendor contracts and what investments they can make to leverage the opportunities presented as part of their strategic planning.