Information Blocking
“Am I an Actor?”
from Gravely Group’s Information Blocking Decision Tool
Gravely Group has developed an Information Blocking Decision Tool to assist individuals and entities who may be impacted by the Information Blocking Regulations promulgated by the Office of the National Coordinator of Health Information Technology (ONC) in their Final Rule, 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, published in May 2020. Gravely Group developed the Information Blocking Decision Tool primarily with “Actors” in mind (i.e., those who are prohibited from engaging in information blocking). However, we also believe it to be a useful tool for everyone who engages (or wishes to engage) with Actors for purposes of accessing, exchanging, and/or using electronic health information (EHI). The question is not whether you or your organization will be impacted by the Information Blocking Regulations but how you or your organization will be impacted.
The Information Blocking Decision Tool begins with the analysis: “Am I an Actor?” We wanted to make this portion of the Information Blocking Decision Tool available to anyone free of charge because we want everyone to understand what role they have in relation to the Information Blocking Regulations. Even if you find that you are likely not an Actor, you will probably discover that you engage with Actors, making this analysis and the complete Information Blocking Decision Tool relevant to you, as well.
Section I: Am I Subject to the Information Blocking Regulations Promulgated by ONC?
Am I an Actor?
Why is this important? You need to know if you are an Actor and subject to the Information Blocking Rule. In some cases, such as for healthcare providers, the answer is a pretty straightforward “yes.” For organizations that develop or offer health IT, the answer is more complicated and requires some attention. For organizations that are engaged in the exchange of health information, the answer can also be pretty complicated and requires careful analysis. This is why we begin the Decision Tool with the question: “Am I an Actor?”
- Are you a healthcare provider?
Yes – You are probably an Actor and, therefore, subject to the Information Blocking regulations.
- You should keep going to see if you might be more than one type of Actor.
- Otherwise, jump down to “So, Are You an Actor? – Recap.”
No
- Proceed to evaluate whether you are another type of Actor.
I don’t know – If you are an individual or entity that is licensed, certified, or otherwise regulated in the provision of healthcare services, you are probably a healthcare provider Actor. Click here for an unofficial source of the definition of “health care provider” under the Final Rule.
- If you still are not sure, keep going with the analysis. For one thing, you might be another type of Actor. Also, when in doubt, you should assume that you are an Actor until you are able to confirm otherwise.
- Consider reaching out to qualified legal counsel to help you determine whether you meet the definition of this Actor-type.
- Do you develop or offer certified health IT?
Yes – You are probably an Actor and, therefore, subject to the Information Blocking regulations.
- You should keep going to see if you might be more than one type of Actor.
- Otherwise, jump down to “So, Are You an Actor? – Recap.”
No
- Proceed to evaluate whether you are another type of Actor.
I don’t know – If you are an individual or entity that develops or offers health information technology and has one or more ONC-certified health IT modules, you are probably a developer Actor. Click here for an unofficial source of the definition of “health information technology” under the Final Rule. You should also consider whether you have control over any “interoperability element(s)” (unofficial definition available here).
- If you still are not sure, keep going with the analysis. For one thing, you might be the third type of Actor. Also, when in doubt, you should assume that you are an Actor until you are able to confirm otherwise.
- Consider reaching out to qualified legal counsel to help you determine whether you meet the definition of this Actor-type.
- Are you a health information network (HIN) or health information exchange (HIE)?
Yes – You are probably an Actor and, therefore, subject to the Information Blocking regulations.
- Scroll down to “So, Are You an Actor? – Recap.”
No – Then, unless you are one of the first two types of Actors, you probably are not subject to ONC’s Information Blocking regulations.
- However, even if you are not an Actor, Gravely Group’s Information Blocking Decision Tool is likely to be of use to non-Actors who wish to request access, exchange, or use of EHI! So, you can use this section to help you understand whether you are likely requesting access, exchange, or use of EHI from an Actor.
- You are not done quite yet! Scroll down to “So, Are You an Actor? – Recap.”
I don’t know
- Consider these additional questions:
- Are you involved in the use of any technology or services that enables access, exchange, or use of Electronic Health Information (EHI) (unofficial definition available here) among more than two other unaffiliated individuals or entities?
- Do you exercise control, influence, or have the discretion to administer that technology or service or the access, exchange, or use of EHI via that technology or service?
- Is any part of that access, exchange, or use of electronic health information (EHI) for treatment, payment, or healthcare operations, regardless whether you are a Covered Entity or Business Associate under HIPAA?
- Do you have control over any “interoperability elements” (unofficial definition available here)?
- If you answered “yes” to all of the above, you are probably an HIN/HIE Actor.
- If you answered “yes” to any of the above, you may be an HIN/HIE Actor; further analysis is warranted.
- Check out the next section: “So, Are You an Actor? – Recap.”
So, Are You an Actor? – Recap:
- If you answered “yes”—that you are a healthcare provider, a developer/offeror of certified health IT, and/or an HIN/HIE—then you are an Actor under the Information Blocking regulations.
- You are an Actor. Now what? Consider purchasing the complete Gravely Group Information Blocking Decision Tool to assist you in analyzing whether you are engaged in any practices that interfere with access, exchange, or use of EHI, as well as whether any such practices fit within one or more of the Information Blocking Exceptions.
- If you answered “no”—that you are not any of the above—then you are most likely not an Actor under the Information Blocking regulations.
- However, if you were on the fence with any of your answers, you may want to confirm this determination with qualified legal counsel. It is also possible that you may be subject to other, similar regulatory constructs, such as the CMS Interoperability and Patient Access Final Rule.
- Plus, as noted above, Gravely Group’s Information Blocking Decision Tool is likely to be of use to non-Actors who wish to request access, exchange, or use of EHI!
- If you answered “I don’t know” to any of the above, you should assume that you ARE an Actor and consult qualified legal counsel for further analysis and guidance.
- Contact Us for assistance.
- In the meantime, check out Gravely Group’s other free Information Blocking Resources!