By Kim Stanger

Healthcare providers focusing on COVID-19 may have missed the final Interoperability and Information Blocking Rule that was published May 1, 2020 and takes effect November 3, 2020. (45 C.F.R. Part 171). The Rule implements the 21st Century Cures Act and furthers the government’s efforts to enable the exchange of electronic health information (“EHI”) to facilitate better outcomes, lower costs, and greater patient access to information. In general, the Rule prohibits covered actors from blocking the flow of EHI; violations may result in significant civil penalties as discussed below.

Application to Healthcare Providers. The Rule applies to healthcare providers, health IT developers of certified health IT,¹ health information exchanges, and health information networks (collectively referred to as “actors”). “Healthcare provider” is defined to include nearly any entity rendering healthcare, including physicians, practitioners, group practices, hospitals, long term care facilities, clinics, ambulatory surgery centers, and other entities determined appropriate by HHS.²

Prohibited Information Blocking. The Rule generally prohibits “information blocking,” i.e., a practice that the healthcare provider “knows³…. is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information”⁴ unless (i) the practice is required by law, or (ii) the practice fits within one of the exceptions listed below. (45 C.F.R. § 171.103(a)). Information blocking may occur, for example, when a healthcare provider refuses, ignores, delays, or imposes unreasonable conditions in response to requests to share EHI, including requests from patients, other providers, or payors. (See 85 FR 25811). It may occur when contracts, business associate agreements, license terms, or organizational policies unnecessarily restrict data sharing, or when technology is implemented, configured, or disabled so as to limit system interoperability. (85 FR 82511-12). The Rule generally prohibits any practices that increase the cost, complexity or burdens associated with accessing, exchanging or using EHI, or that limit the utility, efficacy or value of EHI such as diminishing the integrity, quality, completeness, or timeliness of the data. (85 FR 25809). Ultimately, “[a]ny analysis of whether an actor’s practices constitute information blocking will depend on the particular facts and circumstances of the case,” including whether the action rises to the level of an impermissible interference, whether the actor acted with the requisite intent, and whether the actor had control over the EHI or interoperability elements necessary to access, exchange or use the EHI in question. (85 FR 25811 and 25820).⁵ Read more