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Are you ready? Let’s look at the rule and make sure we understand what we need to do in order to be in compliance.
What are the Goals of the 21st Century Cures Act?
- Make patient data requests easy and inexpensive
- Allow patients, doctors, and health care systems to benefit from a vibrant application marketplace.
- Improve patient safety
- Prevent information blocking
Let’s look at some situations you may face and see what you need to do.
If you have an existing contract, agreement or other arrangement that prohibits you from sharing data, then that agreement may put you into violation of the Information Blocking provisions of the 21st Century Cures Act.
What to do?
Review all of your contracts with your EHR and digital health vendors and make sure there are no provisions that conflict with the new rule. If you are not sure, please consult with an attorney.
What if you are not using Certified Health Information Technology (Certified EHR)?
The 21st Century Cures Act is not specific to any product. The rule applies to all information that you hold, whether it be in a Certified EHR, an EHR that is not certified, your billing system, your digital imaging system, or even word processing files. It is all subject to the rule.
What about paper records?
The 21st Century Cures Act is about electronic information. For details on paper records, you need to refer to the HIPAA Right of Access Rule.
Do you need to have your patient portal turned on?
This is an interesting question. The short answer is yes, but you do not have to have it turned on until you get a request for patient information through the portal. The moment you get such a request it needs to be turned on. If it takes ‘too long’ to turn on the portal and that results in a delay that the government believes it not reasonable you may be found to be in violation of the Cures Act. It is in your best interest make sure it is turned on now rather than having to scramble the moment you get your first request.
How quickly do I need to make lab results available through the portal?
You need to make lab results available as soon as you get them unless you can demonstrate that releasing the lab results may result in patient harm, this is one of the exceptions to the Cures Act. If you make such a determination, it is vital that you document this decisions process so that you can defend yourself in and investigation.
What about “Draft Notes” and incomplete lab results?
Draft notes and lab results that are not finalized MAY not be appropriate to disclose or exchange due to the incomplete nature of the results. But if the information in the Draft note or incomplete lab result was used to make a medical decision then it must be disclosed.
Are there any exceptions to the Information Blocking provision of the Rule?
Yes, there are eight (8) exceptions to the rule
- Preventing Harm Exception
It will not be information blocking for an actor to engage in practices that are reasonable and necessary to prevent harm to a patient or another person, provided certain conditions are met. - Privacy Exception
It will not be information blocking if an actor does not fulfill a request to access, exchange, or use EHI in order to protect an individual’s privacy, provided certain conditions are met. - Security Exception
It will not be information blocking for an actor to interfere with the access, exchange, or use of EHI in order to protect the security of EHI, provided certain conditions are met. - Infeasibility Exception
It will not be information blocking if an actor does not fulfill a request to access, exchange, or use EHI due to the infeasibility of the request, provided certain conditions are met. - Health IT Performance Exception
It will not be information blocking for an actor to take reasonable and necessary measures to make health IT temporarily unavailable or to degrade the health IT’s performance for the benefit of the overall performance of the health IT, provided certain conditions are met. - Content and Manner Exception
It will not be information blocking for an actor to limit the content of its response to a request to access, exchange, or use EHI or the manner in which it fulfills a request to access, exchange, or use EHI, provided certain conditions are met - Fees Exception
It will not be information blocking for an actor to charge fees, including fees that result in a reasonable profit margin, for accessing, exchanging, or using EHI, provided certain conditions are met. - Licensing Exception
It will not be information blocking for an actor to license interoperability elements for EHI to be accessed, exchanged, or used, provided certain conditions are met.
For more details on the exceptions, visit https://www.healthit.gov/cures/sites/default/files/cures/2020-03/InformationBlockingExceptions.pdf
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