Streamlining the flows of health data has the potential to revolutionize the healthcare sector by fueling the development of new innovative technologies, such as artificial intelligence (AI), and increasing access for patients. However, obstruction by self-interested companies has blocked meaningful improvements in data flows, harming patient care and undermining competition. Nearly a decade ago, Congress acted to outlaw information blocking and gave the Department of Health and Human Services (HHS) the authority to develop and enforce regulations that plague the ecosystem. Unfortunately, the lack of enforcement of information blocking regulations has rendered them effectively useless and left us with a system that delays patient care, increases risk of errors, and is a significant barrier to healthcare access.
To lay the groundwork, let’s start with a definition of what we mean by blocking. Information blocking practices are those that are likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information (EHI). Information blocking rules apply to developers of certified health IT, health information exchanges (HIEs) and health information networks (HINs), and healthcare providers. Blocking can present itself in various ways, such as intentionally withholding a patient’s health information, hindering timely access of patient information, and restrictions to access that limit the interoperability of health IT, to name a few examples.
HHS’ information blocking rules, finalized in 2020 and put into effect in 2021, are based on the 21st Century Cures Act, passed by Congress in 2016. One of the main goals of the Cures Act was to promote interoperability (the ability for systems, devices, and software to work together) by defining and prohibiting illegal information blocking practices that stall innovation, delay care coordination, and undermine timely and effective clinical decision-making. Since the regulations were finalized, the Connected Health Initiative has consistently heard that the rules are not being taken seriously because they aren’t being enforced. While some are implicitly violating the rules (e.g., offering noncompliant information exchange mechanisms that do not work in practice while simultaneously offering functional solutions in parallel for a higher fee), others are unapologetically ignoring the rules. Sadly, these bad actors have a competitive advantage over those acting in good faith and taking the extra needed steps to comply with the law. Such a situation is the opposite of what Congress intended when it passed the Cures Act.
The Trump Administration has made clear that it believes digital health solutions are a foundation for healthcare system modernization and improvement. In pursuing this sweeping goal, the Administration should be sure not to look past a necessary initial, and overdue, step in the right direction.
Without adequate information flows, patients will remain unable to truly control their own health data, and new cutting-edge solutions in AI and other areas will not be developed. The Cures Act and the regulations implementing it are already in place. HHS and the Administration can take immediate action to begin enforcing the law today.
CHI calls on HHS to provide for predictability by resolving current information blocking complaints, publishing its findings, and proceeding with further necessary action to deter actors from continuing information blocking activity based on that experience. To maintain transparency, HHS should build on its existing work and develop additional rule clarifications and practical guidance with specific examples and recommendations on the application of information blocking exceptions.
Without these actions, the Administration’s efforts to leverage the power of patient-generated health data using AI tools more broadly that improve patient outcomes and augment population health management will be significantly disrupted. With this focus, in parallel with other important policy changes across areas where we continue to work with the Administration, overdue positive transformation of the American healthcare system can be accomplished.
