With more and more of its healthcare clients seeking help understanding the detailed requirements for implementing the new information-blocking rules put in place under the 21st Century Cures Act, law firm Davis Wright Tremaine decided to create a new Information Blocking Toolkit to help others manage their compliance.

WHY IT MATTERS

The info-blocking final regs, published March 9 by the Office of the National Coordinator for Health IT as a way to enable more widespread access, use and exchange of patient data, go into effect on November 2.

Healthcare providers, vendors, health information exchanges and other organizations could be subject (once an enforcement mechanism is in place) to penalties as high as $1 million per violation should they interfere with the access, exchange or use of electronic health information.

ONC named eight designated exceptions where blocking may be allowed, but they have specific criteria that must be met.

As Ingrid Brydolf, cochair of the healthcare practice at Davis Wright Tremaine, explained in a news release: "When a doctor delays the release of test results because she does not believe the patient will understand them without a discussion; or when an employee ignores a request from a competitor for patient information as part of a research project; or when a contract includes restrictions on how patient information may be further used and disclosed – each practice is potentially information blocking and must be documented as falling under an exception."

To help providers get a better grasp on the complexities of those situations and other details of the 320-page final rule, the toolkit offers a tool to identify practices that may involve information blocking, resources to help analyze each practice under the info blocking regulations, a template to help with designing a policy prohibiting information blocking, and more.

"These new regulations turn traditional privacy laws on their head and creep into every operational facet of the organization," said Adam Greene, a partner in DWT's Washington, D.C., office.

"As we examined the new rules closely with our clients, we recognized the need to provide a toolkit that could convert these complex regulations into a structure that organizations could implement quickly. We're pleased to make this resource available with the compliance date now two months away."

Healthcare organizations interested in purchasing the toolkit should contact Greene, according to the law firm. Because it involves legal advice, entities will need to enter into an engagement letter with Davis Wright Tremaine, which can be limited in scope to the toolkit.

THE LARGER TREND

The COVID-19 crisis has put a spotlight on the importance of ONC's info-blocking policy. As National Coordinator for Health IT Dr. Donald Rucker said recently: "If we'd had this rule a few years ago, we'd be in a far better spot."

But beyond the current historical moment, the main goal of the ONC rules are simple: to "give the patient agency," he explained.

"Rather than the patient being purely subject to the combination of what the payers and the large providers have negotiated, this is a way to give patients the consumer power that they have in the rest of their lives," he said.

During a recent HIMSS Learning Center webinar, panelists from Kaiser Permanente, Penn Medicine and HIMSS explored the technology and policy imperatives of ensuring 21st Century Cures Act compliance and offering greater interoperability while managing through the crisis posed by a global pandemic.

ON THE RECORD

"The more we delved into the regulations, the more we realized the Herculean task of identifying and analyzing each information blocking practice," said Greene. "We believe the toolkit will make compliance far more manageable and will deliver significant value to legal counsel, compliance officers, and privacy officers at healthcare providers of all kinds."

Green will be copresenting a discussion at the HIMSS Healthcare Security Forum titled Are You Ready for Increased Interoperability and Patient Access? It's scheduled for Monday, December 7, from 3:05-3:30 p.m.