Earlier this month, the Department of Health & Human Services released its final rule entitled the “21st Century Cures Act: Interoperability, Information Blocking and the ONC Health IT Certification Program.” The rule prohibits any activity that limits or inhibits the use, exchange or access of electronic health information (EHI). The 1,200+ page rule document outlines comprehensive policies that prohibit information blocking to promote interoperability for electronic health information – as well as updates to the Health IT Certification Program that are designed to enhance interoperability.
Upon the rule’s final publication (which is yet to be determined but likely to be around September 2020), healthcare providers, health IT developers and health information exchanges and networks will have six months to get into compliance with these new regulations. However, the rule will not be fully “enforced” until civil monetary penalties (CMPs) have been established by the HHS Office of the Inspector General (OIG). Experts anticipate additional detail will be forthcoming from OIG in the future in regards to enforcement.
The new rule comes nearly five years after Congress passed the 21st Century Cures Act – which was the first step in this process that was established in 2016 to make it easier for patients and providers to access EHI without barriers. The final rule indicates that patients should be able to access their personal electronic medical record (EMR) at no additional cost and that providers across various health systems should be able to choose the IT systems or tools they think are best without technical hassles or financial barriers. Over the next 24 months, lawmakers want patients to have the ability to choose whatever apps they want to organize and access their personal medical records – and allow them to compare costs, research and understand treatment options and expected health outcomes. In simple terms, they’re hoping to allow healthcare consumers to behave like they do in just about every other aspect of their lives when it comes to making informed healthcare choices and managing their health.
For healthcare providers like doctors and hospitals, this change brings many benefits. Ideally, it will make it much easier for patients to get their own health information without any help from the provider – other than the initial step the provide must make to ensure the information is available digitally via a patient portal. (Think – no more complex medical records release procedures, etc.) Similarly, it will allow providers to choose the software and tools they want – from a competitive market without limitations that have previously been put into place to protect profits for technology companies. Finally, this new rule should have a significant impact on patient safety. Having access to a patient’s full picture of health history, conditions and treatments – and preventing the blocking of information – will always be in the best interest of patients.
The new HHS rule is published by the Office of the National Coordinator for Health IT (ONC) and also puts standards into place as it relates to application programming interface (API) development. This will foster innovation and choice for everyone impacted – to include not only patients, but the entire healthcare continuum of doctors, hospitals, managed care companies and employers alike.
As with most rules, there are exceptions. In this case, ONC has defined eight exceptions that explain when certain practices would not be considered information blocking as it relates to: preventing harm; privacy; security; infeasibility; health IT performance; content & manner; fees; or licensing. The specifics of these exceptions are complex and should be reviewed carefully by hospital legal and compliance departments to ensure adherence.
Want more information about HHS’ final rule and how it might impact your organization? For more information, here are some helpful resources.
- Download the Final Rule
- View the Regulatory Timeline
- Read the Exceptions Explained
- Learn What the Rule Means for Clinicians
GeBBS Healthcare Solutions and its expert team of executives and coding professionals have been briefed on this important rule. If you have further questions about what this rule may mean for your organization, contact us at (888) 539-4282 or request for consultation.