Author: Mark J. Segal, PhD., FHIMSS Principal, Digital Health Policy Advisors, LLC
Note: The post was updated on June 23, 2022 to reflect revised regulatory dates in the just released Spring 2022 Unified Agenda of Regulatory and Deregulatory Actions.
The summer (and fall) of 2022 promises to bring critical milestones for interoperability and data access, tying together many strands linking back to the 2009 HITECH legislation (i.e., Meaningful Use and its successors) and the 2016 21st Century Cures (Cures) legislation. Community participants with an interest in data sharing and interoperability, including those with regulatory compliance responsibilities, will want to track these events very closely.
One major driver for enhanced data sharing is a set of regulations, both proposed and final, that will further implement the Information Blocking provisions of Cures. A second involves significant progress in implementing the Trusted Exchange Framework and Common Agreement (TEFCA), which was called for in Cures. Finally, the Office of the National Coordinator for Health IT (ONC) continues its work in refining data sets and adopting standards used by the industry to move us closer to semantic interoperability. Four common themes across these efforts are:
- Enhanced patient access to their health data;
- The use of HL7® FHIR®-based Application Programming Interfaces (APIs) to allow a more efficient exchange of individual data elements and a robust app economy for health data consistent with state and federal privacy and security requirements;
- A focus on expanding the data available for exchange, including via a standardized set of data elements; and
- A shift from the HIPAA privacy rule approach to data access that focuses on when data may be accessed and exchanged to a model that uses regulations and voluntary agreements to establish when patient data must be provided upon a valid request.
In terms of Information Blocking, we are looking at five likely major events by October:
- The Department of Health and Human Services Office of the Inspector General (OIG) is expected to publish in September a long-awaited Final Rule on assessing civil monetary penalties (CMPs) for information blocking by two of the three Actor categories subject to the Information Blocking prohibition: Providers and Health Information Networks/Health Information Exchanges (HIN/HIE). This Final Rule will build on an April 2020 Proposed Rule that described the OIG’s approach on such issues as enforcement priorities, determining the size of penalties (up to $1 million per violation), and how a “violation” will be defined.
- Sometime this summer or fall, HHS may also issue a long-awaited proposed rule on “appropriate disincentives” for Providers, who are not subject to OIG-determined CMPs, per Cures.
- In October, ONC is slated to issue a Proposed Rule that is expected to include some proposed regulatory refinements to its May 2020 Information Blocking Final Rule. These proposed changes are likely to respond to industry questions and concerns that have emerged since the release of the Final Rule, including those addressed on ONC FAQs.
- In September, the Centers for Medicare and Medicaid Services is expected to issue a proposed rule replacing an earlier proposed and final rule withdrawn by the Biden Administration on interoperability and prior authorization, including proposed changes to the Medicare payment incentive program promoting interoperability requirements.
- Finally, on October 6, 2022, the definition of Electronic Health Information (EHI) subject to the Information Blocking regulations will significantly expand from the current constrained definition grounded in version 1 of the US Core Data for Interoperability (USCDI) to a definition based on electronic Protected Health Information (ePHI) in the HIPAA Designated Record Set (DRS), which includes clinical and billing information used to make decisions about patients.
This shift to the full EHI definition has led to considerable industry concerns and efforts on how to implement this expanded set of data that must be available for access, exchange, or use under the Information Blocking rules (subject to any “exceptions” or other regulatory limits). This concern has been heightened by the complexity of the DRS data held within and across Provider health IT systems. It also reflects the fact that the ONC 2015 Update HL7 FHIR-based APIs certification criteria that must be in use by the end of 2022 and the EHI Export function slated for the end of 2023 implementation, both of which will help support expanded EHI access, will not be widely available by early October 2022.
In addition to its work on Information Blocking, ONC has been engaged with its Recognized Coordinating Entity (RCE), the Sequoia Project, on accelerating the implementation of the TEFCA, which will help realize the decades-long march to a true nationwide, standards-based trusted exchange architecture that includes multiple exchange purposes, including treatment and individual patient access.
Building on its first-quarter 2022 work: publication of the Common Agreement Version, QHIN Technical Framework (QTF) Version 1, and an FHIR Roadmap, the RCE has since issued multiple technical documents and standard operating policies (SOPs) that extend the Common Agreement. Notably, it also issued on May 16, 2022, a draft Qualified Health Information Network (QHIN) Onboarding and Designation Standard Operating Procedure (SOP) and a draft QHIN Application, with comments that were due June 15, 2022. The RCE expects to finalize these documents later this summer, opening the membership application “window” for QHINs, the initial set of which are likely to be named later this year.
Finally, ONC is continuing its work on standards, with the summer of 2022 likely to see the publication of the third version of the USCDI and an update to the Standards-Version Advancement Process (SVAP), effective for use in the ONC certification program in August 2022. The SVAP Is a voluntary process to enable health IT developers to incorporate newer versions of Secretary-adopted standards and implementation specifications. This SVAP update could include version 2 of the USCDI and other standards updates.
So, a busy summer (and fall) to be sure, but one that will likely see major developments worthy of our attention, engagement, and optimism. “Enjoy” all of this to be sure, but especially really enjoy your time with family and friends.
Mark Segal, PhD., FHIMSS, Principal, Digital Health Policy Advisors, LLC. Member and Past Chair of the EHI Policy Steering Committee. June 23, 2022. Twitter @msegal111