Will the New Information Blocking Rule Really Improve Healthcare Data Sharing?

Healthcare, Regulatory News

May 20th, 2020

The information blocking rule aims to improve interoperability and patient care. Will it actually improve healthcare data sharing or is it an empty promise?

information blocking rule

In March, HHS published the ONC’s new interoperability and information blocking rule. These new rules are meant to help implement certain provisions of the 21st Century Cures Act. The objective is to improve patient access to their healthcare data and prohibit information blocking among providers, payers, and other stakeholders. Looking at the components of the information blocking rule, many are asking if it will really impact healthcare data sharing?

What Does the Information Blocking Rule Define and Clarify?

Even though interoperability and data sharing have been essential in healthcare for some time, it’s never been an easy road. Healthcare data is complex and requires privacy and security provisions. Payers and health systems have been guilty of “information blocking,” restricting what they share and with whom. 

The rule seeks to eliminate some aspects of blocking and hold accountable IT developers and EHR vendors as a condition of certification. The Final Rule on information blocking seeks to support Section 4004 of the Cures Act. This section created new federal penalties to deter against information blocking. 

The new rule clarifies the definition of information blocking as “the intentional withholding of patient health information either from provider to provider or provider to patient.” It also establishes who is subject to this rule. It also finalizes any exceptions to information blocking with eight categories that involve preventing patient harm, security concerns, infeasibility, and reasonability. 

This part of the rule was to go into effect on June 30, 2020. But due to COVID-19, it’s not effective until November 2, 2020. 

Who Is Impacted by Information Blocking?

The rule includes EHR developers, health information exchanges and networks, and providers. Providers are described as “covered actors.” EHR vendors now face new certification rules for compliance. 

Providers would be subject to sanction if they knowingly engage in information blocking that interferes or prevents data access. The term healthcare provider is very broad and includes hospitals, surgical centers, labs, pharmacies, long-term care facilities, and individual practitioners.

What Is the Enforcement?

If a provider is accused of information blocking, the OIG will investigate such complaints. Should a violation occur, the provider would not be subject to the $1 million per violation, as noted in Section 4004. Congress has directed the OIG to refer violations to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary sets forth through notice and comment rulemaking.”

However, HHS has not identified which agencies should be involved or what the disincentive is. Thus, enforcement and penalties are still up in the air. The OCR, which enforces HIPAA, could be a probable agency. CMS could also act as an enforcer and has already stated it will begin to publish providers that do not list or update contact information, per the interoperability and information blocking rule. 

Will the Rule Improve Data Sharing?

information blocking

Interoperability has been hard to achieve because platforms like EHRs do not allow for outside accessibility, per their design. This practice protects businesses but harms patient care and public health in general. 

So now, it’s like completely changing a business model. On top of this transformation, the ONC has defined a framework on how EHR vendors can reach the new certification requirements but not how to do it. There is much dysfunction in the world of healthcare data, and EHR vendors and others have voiced concerns about privacy issues that go along with enforcing these rules.

The rules are not perfect by any means. The objective behind them is clear—accessibility and portability—that can then improve care models and possibly reduce healthcare costs. For example, if a patient’s records were accessible across the board, then it could minimize lab tests or imaging being duplicated. Without specific standards in place for data sharing, the effort and investment may not be feasible. 

Is the Rule and Empty Promise?

Because there are so many unknowns regarding how to do it and how to enforce it, it may seem like an empty promise right now. Paradigm shifts involve much change, and that won’t happen rapidly. On top of this, add the COVID-19 pandemic, which has its own data sharing woes

For this to work and equally benefit providers, payers, patients, and software vendors, data sharing must be consistent and structured. No matter what role you play in the information blocking rule, it’s likely you need a partner that deeply understands how to convert and migrate PHI between applications. That’s exactly what we know how to do. Find out more about how we can be your data liaison.  

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