Home Health Care Enforcement landscape for HHS data-sharing rules is hazy, experts say

Enforcement landscape for HHS data-sharing rules is hazy, experts say

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Though the federal interoperability and information blocking rules went into effect a week ago, questions still remain about how exactly they will be enforced.

The government has not yet provided any finalized direction on this, and healthcare experts say that it is unclear how things will shake out, so it’s best if providers are proactive about compliance.

The price tag for violating the Department of Health and Human Services’ interoperability and information blocking rules could be hefty. For health IT developers and health information networks/exchanges, the HHS has proposed penalties of up to $1 million per violation, said Amber Ellis, a healthcare attorney at Holland & Hart, in an email.

There are no proposed penalties yet for healthcare providers, but HHS is expected to establish “[an] appropriate disincentive,” though it is not clear what shape that will take, she said.

One way to gain clues into potential enforcement action is to look at which agencies within HHS have a purview over the different actors who are bound by the new regulations.

For instance, the Office of the National Coordinator for Health Information Technology has purview over certified health IT developers, as it runs the health IT certification program, said Ye Hoffman, a senior consultant with the Advisory Board who tracks the healthcare regulatory environment, in a phone call. On the certification side of things, information blocking rules are linked to the maintenance of certification conditions.

So, theoretically, if a health IT developer is found to be non-compliant with the new rules, they could face consequences under the certification program, such as their products being de-certified.

“Most of [the developers’] clients are going to really be concerned if the product they are using is potentially going to be de-certified,” Hoffman said.

In addition, the ambiguities that remain in the definition of information blocking could mean that the agency will initially target more egregious conduct, said Reece Hirsch, a partner at Morgan Lewis, in an email.

“[For example,] conduct by a developer that clearly impedes the flow of health information for the developer’s commercial gain,” he said.

Another avenue for enforcement could be through HIPAA, the Advisory Board’s Hoffman said. It is possible that if during a HIPAA investigation an organization is found to be engaging in information blocking, it could affect how the investigation will play out, and it may or may not impact any potential HIPAA penalties the organization might incur, she said.

To contend with this hazy enforcement landscape, providers need to be proactive in assessing their practices to confirm compliance, Holland & Hart’s Ellis said.

For example, blanket policies allowing delays in providing lab results and other records requested by patients may no longer be acceptable practices, she said. Instead, providers need to examine patient requests for information on a case-by-case basis.

In addition, as providers and health IT developers re-examine their patient information data flows, both retrospectively and for new contracts, they need to keep the information blocking rules top-of-mind, Morgan Lewis’ Hirsch said.

“Even if you’ve reviewed data sharing from a privacy perspective, the information blocking standard creates a new lens through which to evaluate arrangements,” he said.

But providers and IT developers should keep in mind that, ultimately, these rules and their enforcement will evolve.

“A lot of folks are thinking of the April 5 date as the deadline for these rules — it’s really more of a starting line, in fact,” said the Advisory Board’s Hoffman. “It’s going to evolve. Whatever the landscape is now in terms of the policies, the health IT capabilities, what patients and caregivers and others in the industry expect for data sharing, that is going to change over time.”

Photo: putilich, Getty Images

 

 

 

 

 

 

 

 

 

 

 

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