The 21st Century Cures Act Information Blocking Rule's applicability date of April 5, 2021, is just around the corner. Nevertheless, healthcare providers are still struggling with understanding their obligations under the new Rule.
One of the biggest questions is whether clinicians can intentionally and routinely delay the release of categories of electronic health information (EHI) in order to first speak with the patient. A recent Office of the National Coordinator for Health Information Technology (ONC) Frequently Asked Question (FAQ) makes clear that such a delay would constitute "interference" under the Rule. But that is not the end of the inquiry, as providers can still assess whether their practices are reasonable and, therefore, not information blocking.
When the Information Blocking Rule was first published, many believed that it required healthcare providers to proactively publish all EHI to their patient portals. In a January 15, 2021, FAQ, the ONC clarified that the Rule is not a proactive obligation but, rather, is only triggered by a request for EHI.
The FAQ included the following warning, though:
We note, however, that a delay in the release or availability of EHI in response to a request for legally permissible access, exchange, or use of EHI may be an interference under the information blocking regulations (85 FR 25813, 25878).
This led to some confusion regarding whether test results and other EHI must always be available, at least in response to a request, in real time and without delay.
On March 19, 2021, ONC issued an additional FAQ addressing questions about the permissibility of delaying the release of EHI. The FAQ makes clear that intentionally and unnecessarily delaying the release or availability of EHI generally will be an "interference" under the Information Blocking Rule:
Q: When would a delay in fulfilling a request for access, exchange, or use of EHI be considered an interference under the information blocking regulation? *3/19/2021*
A determination as to whether a delay would be an interference that implicates the information blocking regulation would require a fact-based, case-by-case assessment of the circumstances.
That assessment would also determine whether the interference is with the legally permissible access, exchange, or use of EHI; whether the actor engaged in the practice with the requisite intent; and whether the practice satisfied the conditions of an exception. Please see 45 CFR 171.103 regarding the elements of information blocking.
Unlikely to be an Interference.
If the delay is necessary to enable the access, exchange, or use of EHI, it is unlikely to be considered an interference under the definition of information blocking (85 FR 25813).
For example, if the release of EHI is delayed in order to ensure that the release complies with state law, it is unlikely to be considered an interference so long as the delay is no longer than necessary (see also 85 FR 25813). Longer delays might also be possible and not be considered an interference if no longer than necessary, in scenarios where EHI must be manually retrieved and moved from one system to another system (see, for example, 85 FR 25866-25887 regarding the manual retrieval of EHI in response to a patient request for EHI).
Likely to be an Interference.
It would likely be considered an interference for purposes of information blocking if a healthcare provider established an organizational policy that, for example, imposed delays on the release of lab results for any period of time in order to allow an ordering clinician to review the results or in order to personally inform the patient of the results before a patient can electronically access such results (see also 85 FR 25842 specifying that such a practice does not qualify for the "Preventing Harm" Exception).
To further illustrate, it also would likely be considered an interference:
- Where a delay in providing access, exchange, or use occurs after a patient logs in to a patient portal to access EHI that a healthcare provider has (including, for example, lab results) and such EHI is not available—for any period of time—through the portal.
- Where a delay occurs in providing a patient's EHI via an API to an app that the patient has authorized to receive their EHI.
Okay. Intentionally delaying release of lab results to a portal to provide clinicians an opportunity to first speak with the patient is "likely to be considered an interference" and, therefore, is prohibited information blocking. Case closed. Right?
Not so fast. The ONC FAQ clearly discourages the practice of intentionally delaying the release of lab results and other EHI to the portal (unless an exception, such as the Preventing Harm exception, applies). There is little question that eliminating any such delays is the best way to reduce the risk of information blocking. But is it information blocking to intentionally delay the release of EHI where a provider believes it is best for the clinician to first speak with the patient? The FAQ does not fully answer this question. This is because the FAQ does not address the reasonableness component of the Information Blocking Rule.
Let's revisit the elements of information blocking at 45 C.F.R. § 170.103(a):
Information blocking means a practice that—
- (1) Except as
- Required by law or
- Covered by an exception set forth in [45 C.F.R. §§ 171.201 to .303], is
- Likely to interfere with access, exchange, or use of electronic health information; and
- (2) If conducted by a health information technology developer, health information network or health information exchange, such developer, network or exchange knows, or should know, that such practice is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information; or
- (3) If conducted by a healthcare provider, such provider
- Knows that such practice is unreasonable and
- Is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.
If a healthcare provider intentionally delays the release of a category of sensitive lab results to the portal for three days to provide ordering clinicians an opportunity to speak with patients first, then this practice likely is not required by law (unless a law such as Or. Rev. Stat. § 438.430(3) applies and requires the delay).
The practice likely does not fall under an exception. For example, the Preventing Harm exception generally only applies to individualized determinations, not routine delays of releasing categories of EHI. The ONC FAQ makes clear that the practice is likely to be considered an interference with access, exchange, or use of EHI. But one element still remains. For the practice to be information blocking, the healthcare provider must know that the practice is unreasonable.
If the healthcare provider believes that delaying the release of the EHI for three days to provide clinicians an opportunity to first speak with patients is reasonable—as a means to improve patient care and avoid confusion and emotional distress—then the practice is an interference, but it is not information blocking (because the provider does not know the practice to be unreasonable).
At what point does a delay become patently unreasonable, such that the provider must know the practice to be unreasonable? Seven days? 15 days? 30 days? That remains an open question. Is it only reasonable to delay release of certain categories of EHI and, if so, which categories? Another good question.
What is clear is that ONC is promoting the immediate release of EHI to the patient portal, without intentional delay, whenever possible. Doing so is likely best for the patient in most cases. But the new FAQ should not be read to mean that it is always information blocking to intentionally delay the release of EHI. Rather, for healthcare providers, even if "interference," it is only information blocking if the provider knows the practice to be unreasonable.
With the Information Blocking Rule's applicability date fast approaching, providers should carefully review circumstances where they are intentionally delaying the release of EHI to the portal. From an information blocking perspective, the most conservative path is to eliminate all such delays.
But clinicians may have strong reasons to want to continue to delay the release of certain EHI to the portal. If the provider wishes to continue to delay certain EHI releases, it may wish to thoroughly document the reasonable basis for its decision. "This is the way we've always done it" likely is not going to cut it. The provider should then be ready to defend to a regulator that it believed the practice to be reasonable and, therefore, it was not information blocking.
Finally, remember that the reasonableness standard is only available to healthcare providers, not to health information technology developers, health information networks, or health information exchanges (including when healthcare providers are acting in such capacities, such as when they offer certified electronic health record technology to community physicians).
For more information about operationalizing compliance with the Information Blocking Rule, you may wish to consider the DWT Information Blocking Toolkit, or you may contact a DWT attorney for assistance.