Consider the heap of information that medical practices, clinics, hospitals, and other healthcare service providers collect, store and analyze. It is difficult to overstate the power of all of this data stored on providers’ servers. But it’s not useful if the patients face issues in accessing their records. And the providers have to take pains to safeguard valuable information of patient records against criminal hackers.
One of the biggest challenges facing organizations is achieving a balance between all of the information they collect and making it available and useful for the patients. This is why the 21st Century Cures Act Final Rule on Interoperability and Information Blocking is so essential. It’s a federal mandate the government issued to stop the blocking of electronic health information between health systems, apps, and devices.
What is the 21st-century cures act?
On Dec. 13, 2016, the Cures Act was signed into law by President Barack Obama. The bipartisan legislation seeks to increase choice and access for patients and providers. It contains amenities to streamline development and delivery for drugs and medical devices, accelerate research into serious illnesses, address the opioid crisis, and improve mental health services.
The Cures Act also seeks to ease regulatory burdens associated with the use of electronic health record (EHR) systems and health information technology (IT). It contains provisions focused on advancing interoperability and requiring developers not to engage in information blocking — or preventing or interfering with the access, exchange, or use of electronic health information (EHI).
21st Century Cures Act 2022 Summary
The ongoing development of technology in the 21st century needs regulations to protect people’s data while also setting up systems that enable individuals to get more value out of this information.
Two thoughts are in place now. First, patients have the right to see the information about them being stored in their clinical notes. Access is through a secure patient portal.
Second, doctors, nurse practitioners, and clinics will have to release reports, lab results, and other information to patients immediately.
If your organization hasn’t initiated a patient portal, you should know that it’s easy to set up and should be considered standard with your electronic health records software.
As per Health Information Technology, a major benefit to patients is that the Final Rule provides for “modern smartphone apps to provide them convenient access to their records”. They will also gain transparency about the cost of care and potential outcomes.
According to the U.S. Department of Health and Human Services, The deadline for standardized API functionality to allow patients to be able to use their smartphones to access their records like connect with their lab data, is December 21, 2022.
Interoperability Standard With USCDI
Prepare your team for the decreed switchover from the Common Clinical Data Set to the new United States Core Data for Interoperability (USCDI). And the deadline for doing this is in March 2022 for software developers to make changes addressing support for data elements such as vital signs in pediatrics, clinical notes, and patients’ contact information.
Legal Penalties for Violating the 21st Century Cures Act
The government body in charge of investigating any claims of information blocking in the context of the 21st Century Cures Act Final Rule is the Office of the Inspector General. According to Impact Advisors, the penalty for blocking information can be as high as $1 million per violation.
Exceptions in information blocking
What if a provider is unable to share information in the format the patient requests? Should the provider send the patient to the EHR vendor? Because practices are viewed as the guardians of information, the immediate answer should be no. Directing the patient to the EHR vendor could be taken as information blocking.
You can, however, reach out to your EHR vendor and walkthrough information blocking and the exceptions to understand which if any may apply. Finding out whether information requests fall into the exception category starts with a clear understanding of the eight exceptions mentioned in this 21st Century Cures Act summary:
- Preventing Harm: If a practice determines it will prevent harm to a patient or someone else.
- Privacy: An actor can block information to protect an individual’s privacy, in the context of HIPAA privacy safeguards.
- Security: You can prevent information from being released if it would pose a security risk, but this must be applied consistently.
- Infeasibility: If it’s not technically possible to safeguard patient information, you can block its release. However, you’ll then need to create a policy or implement a security determination
- Health IT Performance: It’s not a violation of the updated rule if health IT professionals need to temporarily block access or hinder the system’s performance when the system is shut down for upgrades or to otherwise comply with service level agreements.
- Content and Manner: Within 24 months of the final rule’s publishing date in March 2020, actors must release electronic health information according to the United States Core Data for Interoperability Standard (USCDI).
- Fees: The government does not consider it to be information blocking if an actor charges fees (even if the fees result in a profit). You must base fees on objective criteria.
- Licensing: When interoperability elements are licensed before people can access electronic health information, it’s not considered to be information blocking.
Within your practice, you should establish a process for evaluating information requests and ensure staff members are knowledgeable about the exceptions involved.
Moreover, you should continue to summarize the 21st Century Cures Act for your staff. It may be helpful to create a checklist or series of checklists that outline the information you need to evaluate.
Preparing staff for compliance with the 21st Century Cures Act Final Rule
As is the case with most governmental regulations, there are a lot of moving parts to be aware of when it comes to the Cures Act. Your staff already has their hands full just dealing with their regular duties serving patients. But now it’s time to prioritize your focus so you can get everyone up to speed.
Stay updated with Zee Medical Billing and track all the details compliant with the 21st Century Cures Act Final Rule.
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