The Office of the National Coordinator for Health Information Technology (ONC) final rules on healthcare interoperability and “information blocking” present complex clinical, operational and security challenges. Hospitals, health IT vendors and other stakeholder organizations will need to strategize around how to maximize the benefit from these policies while also balancing continued investment in and commitment to technical infrastructure.
Title IV of the 21st Century Cures Act (Cures Act) was “designed, [in part] to advance interoperability; support the access, exchange, and use of electronic health information (EHI); and address occurrences of information blocking.”1 The Cures Act definition of interoperability calls for “’all electronically accessible health information’ to be accessed, exchanged and used ’without special effort on the part of the user’.”2
Information blocking, according to 45 CFR 171.10 effective November 4, 2020 of the Federal Register, “means a practice that is likely to interfere with access, exchange, or use of electronic health information; and if conducted by a health IT developer of certified health IT, health information network or health information exchange, such developer, network of exchange knows, or should know, that such practice is likely to interfere with access, exchange or use of electronic health information; and if conducted by a healthcare provider, such provider knows that such practice is unreasonable and is likely to interfere with access, exchange or use of electronic health information.”
The Centers for Medicare & Medicaid Services and The Office of the National Coordinator for Health Information Technology (ONC) rules are final. The Office of the Inspector General rule on enforcement is expected later this year.
Healthcare interoperability would allow for the exchange of information across the continuum of care among end-users, i.e., providers and patients. Improved outcomes, process-of-care efficiencies and less duplication of effort would result. Despite the potential benefits, hospitals lack the electronic health record infrastructure necessary to integrate health information without a substantial manual effort.3 More specifically, barriers to interoperability include inconsistent technical specifications, a lack of standardized terminology, limited capacity (if any) to integrate data from third-party sources (e.g., wearables), disparate user interfaces, and divergent privacy, security and trust standards.4,5
As part of the ONC’s final rule, the United States Core Data for Interoperability (USCDI) establishes “a set of data classes and constituent data elements required to support interoperability nationwide.”6 In addition, expectations for data sharing include open application programming interfaces (APIs).7
Policies enforcing the elimination of information blocking will be essential to facilitate interoperability. This will be balanced by Section 4004 of the 21st Century Cures Act authorizing the Secretary of HHS to identify reasonable and necessary activities that do not constitute information blocking, i.e., exceptions to the rule.
Information Blocking Exceptions
Title IV of the 21st Century Cures Act poses several fundamental questions to providers:
- Do our caregivers and members of the healthcare workforce understand their role in providing patients access to their health information? What are the relevant institutional policies and procedures?
- Do our patients understand their rights to access, exchange and use their health information? What is the patient’s health information experience at our institution?
- Have we done enough to mitigate our risk (compliance, financial)? Do our written polices (clinical and administrative) align with the regulations?
- Have we worked with our vendor partners to ensure that our technology solutions meet the standards?
- Have we reviewed our Release of Information workflow? What are our policies on release of health information? Do our IT solutions have configuration points that impact when and under what conditions information is made available to patients?
- Mark Sugrue, Managing Director | email@example.com
Compliments of FTI Consulting – a member of the EACCNY.