The 21st Century Cures Act required the Office of National Coordinator for Health ITs (ONC) to develop regulations to improve interoperability and patient access to electronic health information (EHI) and deter information blocking. These new regulations took effect November 2, 2020. Patients, clinicians and hospitals, and IT developers are the primary parties to these regulations. However, there have been extensions granted due to the COVID-19 pandemic. The interim rule with comment period is open until April, 2021 and much of the rollout is slated for 2022 and 2023 (see ‘Learn More – Primary Sources’ for dates).
There are multiple facets to these new regulations, including patients having ease of access to their medical records, privacy protection, and the ability to shop for care and manage costs similar to online shopping. Patients will be able to electronically access all of their EHI, structured and/or unstructured, at no cost.
For clinicians and hospitals, the plan is for patient data requests to be easy and inexpensive. This includes directives regarding transparency regarding patient safety and protection of developers’ intellectual property rights.
These new regulations do allow fees and royalties, including a reasonable profit margin, for access to data.
Information blocking is defined as “a practice by a health IT developer of certified health IT, health information network, health information exchange, or health care provider that, except as required by law or specified by the Secretary of Health and Human Services (HHS) as a reasonable and necessary activity, is likely to interfere with access, exchange, or use of electronic health information (EHI).” These new regulations have been developed to discourage information blocking.
The following actors are subject to information blocking policies
However, there are reasonable exceptions where information blocking may be acceptable including (but not limited to)
Those who engage in information blocking are subject to penalties. Penalties could be as high as $1 million per violation should there be interference with the access, exchange or use of electronic health information. Enforcement mechanisms are not yet in place.
Get Guideline Alerts Direct to Your Phone
Please sign up or log in to your ObGFirst to access this Premium Content
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
One of the benefits of an ObGFirst subscription is the ability to earn CME/CE credits from the ObG entries you read. Tap the button to learn more about ObGFirst
You are now leaving the ObG website and on your way to PRIORITY at UCSF, an independent website. Therefore, we are not responsible for the content or availability of this site