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Easing the Regulatory Burden of Electronic Health Records

HHS Secretary Alex Azar recently announced efforts by HHS to reduce the regulatory burden on health care providers created by electronic health records systems (EHR). In December of 2016, Congress enacted the 21st Century Cures Act (the Act). Among the many initiatives included in the Act, Congress recognized the significant regulatory and administrative burdens related to the use of EHRs and other electronic health IT systems. In response, the Act emphasized the importance of reducing those burdens and specifically mandated that the Department of Health and Human Services (HHS) develop a strategy and provide recommendations to accomplish that goal.

In response to Congress's concern over the regulatory burden associated with EHRs, HHS released a draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs on November 28, 2018. The primary goal of this strategy is not only to reduce the burden on EHR end-users but also to improve the care delivery experience for all involved. Notably, HHS Secretary Alex Azar stated:

"Usable, interoperable health IT was one of the first elements of the vision I laid out earlier this year for transforming our health system into one that pays for value. With the significant growth in EHRs comes frustration caused, in many cases, by regulatory and administrative requirements stacked on top of one another. Addressing the challenge of health IT burden and making EHRs useful for patients and providers, as the solutions in this draft report aim to do, will help pave the way for value-based transformation."

Based on the input received by HHS, the draft strategy outlines three overarching goals designed to reduce clinician burden:

  1. Reduce the effort and time required to record health information in EHRs for clinicians;
  2. Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and health care organizations; and
  3. Improve the functionality and intuitiveness (ease of use) of EHRs.

The public comment period on the draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs ends on Monday January 28, 2019 at 11:59:59 PM ET.

©2020 von Briesen & Roper, s.cNational Law Review, Volume IX, Number 10

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About this Author

Stacy Gerber Ward, von Briesen Roper Law Firm, Milwaukee, Corporate and Health Care Law Attorney

Stacy Gerber Ward is a Shareholder and Leader of von Briesen’s Government Enforcement and Corporate Investigations Section. Stacy focuses on helping clients respond to government investigations and conduct internal investigations using her more than 14 years of experience serving as an Assistant United States Attorney for the Eastern District of Wisconsin and most recently as the Deputy Chief of the Civil Division. Stacy investigated and prosecuted individuals and corporations for civil health care fraud and other enforcement matters, including government enforcement...

414-287-1568
Ryan Siehr, von Briesen Law Firm, Milwaukee, Corporate and Health Care Law Attorney

Ryan Siehr is an attorney in the Business Practice Group and serves as chair of the Health Information Privacy and Security Section. Ryan advises hospitals, multi-institutional health care systems, physician groups and specialty providers regarding a variety of transactional health care related matters, including acquisitions, physician agreements, and equipment and office space leasing arrangements. Ryan focuses on assisting these entities with HIPAA compliance, including developing policies and procedures and negotiating business associate, data use, trading partner, and other HIPAA related agreements. Ryan has significant experience with negotiating technology-related agreements in the health care industry, including software licensing, SaaS, ASP, maintenance, project implementation, master services, and development agreements.

Ryan also advises individuals, corporations, and partnerships regarding general corporate transactional matters, including the negotiation and documentation of stock and asset-based transactions involving the selection and formation of business entities, transition planning, including buy and sell agreements, rights of first refusal and restrictions on the sale of equity interests, and the negotiation and documentation of a variety of other contractual arrangements. Ryan also focuses on EAR and OFAC compliance for clients exporting goods out of the United States.

Ryan is a member of the State Bar of Wisconsin and the Milwaukee Bar Association.

414- 287-1595