21st Century Cures Act
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US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory approaches to reducing barriers to the development and adoption of artificial intelligence (AI) technologies. Implementing agencies are agencies that conduct foundational research, develop and deploy AI technologies, provide educational grants, and regulate and provide guidance for applications of AI technologies, as determined by the co-chairs of the National Science and Technology Council (NSTC) Select Committee. To our knowledge, the NTSC has not yet determined which agencies are “implementing agencies” for purposes of the Memorandum.

Submission of Agency Plan to OMB

The “implementing agencies” have 180 days to submit to OMB their plans for addressing the Memorandum.

An agency’s plan must: (1) identify any statutory authorities specifically governing the agency’s regulation of AI applications as well as collections of AI-related information from regulated entities; and (2) report on the outcomes of stakeholder engagements that identify existing regulatory barriers to AI applications and high-priority AI applications that are within the agency’s regulatory authorities. OMB also requests but does not require agencies to list and describe any planned or considered regulatory actions on AI.

Principles for the Stewardship of AI Applications

The Memorandum outlines the following as principles and considerations that agencies should address in determining regulatory or non-regulatory approaches to AI:

  1. Public trust in AI. Regulatory and non-regulatory approaches to AI need to be reliable, robust and trustworthy.
  2. Public participation. The public should have the opportunity to take part in the rule-making process.
  3. Scientific integrity and information quality. The government should use scientific and technical information and processes when developing a stance on AI.
  4. Risk assessment and management.A risk assessment should be conducted before determining regulatory and non-regulatory approaches.
  5. Benefits and costs. Agencies need to consider the societal costs and benefits related to developing and using AI applications.
  6. Flexibility. Agency approaches to AI should be flexible and performance-based.
  7. Fairness and nondiscrimination. Fairness and nondiscrimination in outcomes needs to be considered in both regulatory and non-regulatory approaches.
  8. Disclosure and transparency. Agencies should be transparent. Transparency can serve to improve public trust in AI.
  9. Safety and security. Agencies should guarantee confidentiality, integrity and availability of data use by AI by ensuring that the proper controls are in place.
  10. Interagency coordination. Agencies need to work together to ensure consistency and predictability of AI-related policies.

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Can We Expect to See ONC’s Final Rule on Information Blocking Soon?

A recent update to the Office of Management and Budget (OMB) website suggests that the answer is “yes”—though that depends on how one defines “soon.” According to its website, OMB received the Office of the National Coordinator for Health Information Technology’s (ONC’s) final rule, entitled 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, for review on October 28, 2019.

Based on the rule title, it appears that ONC is ready to finalize its proposals concerning information blocking and related exceptions. Earlier this year, ONC issued a proposed rule that, among other things, proposed to define information blocking and establish seven exceptions to the broad prohibition for reasonable and necessary activities that should not be considered information blocking. For more information about the information blocking provisions of ONC’s proposed rule, see our On the Subjects here and here.

OMB review is one of the final steps in the process before a rule is published in the Federal Register. OMB did not identify a deadline for completing its review. The agency generally has up to 90 days to complete its review and while it can take less time, OMB took longer with ONC’s proposed rule.

ONC received more than 2,000 public comments on its proposed rule, many of which related to information blocking topics such as the broad scope of the proposed definitions for certain covered actors—e.g., health information exchanges and health information networks—as well as the scope of the definition of “electronic health information.” Several large industry stakeholders recently wrote a letter to Chairman Lamar Alexander and Ranking Member Patty Murray of the Senate Committee on Health, Education, Labor and Pensions raising concerns about ONC’s rulemaking efforts to date and recommending, among other things, that ONC issue a Supplemental Notice of Proposed Rulemaking (SNPRM) to seek further input from stakeholders on various information-blocking-related issues. While we do not know the ultimate contents of ONC’s final rule, it does not appear that ONC has pursued the SNPRM path to gain additional public input.

While we wait for ONC to publish its final rule on key policy decisions that will shape the information blocking enforcement landscape moving forward, please do not hesitate to contact your regular McDermott lawyer or any one of the authors of this blog post if you have questions or need assistance related to information blocking.




Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

The 21st Century Cures Act, enacted in December 2016, amended the definition of “medical device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) to exclude five distinct categories of software or digital health products. In response, the US Food and Drug Administration (FDA) issued new digital health guidance and revised several pre-existing medical device guidance documents. FDA also stated that it would continue to assess how to update and revise these guidance documents as its thinking evolved.

Late last week, FDA issued five final guidance documents and re-issued a draft guidance document to better reflect FDA’s current thinking on software as a medical device (SaMD) and other digital health products:

Most of the guidance documents reflect modest changes to prior draft guidance documents that describe categories of low-risk health and wellness devices that FDA does not intend to regulate. FDA’s new draft Clinical Decision Support (CDS) Software guidance, however, provides a new and more detailed analysis of risk factors that FDA will apply to determine whether a CDS tool is a medical device. FDA updated its previously issued draft CDS guidance without finalizing it. Although the new guidance does not explain why FDA is reissuing the CDS guidance in draft, the new draft guidance seems to reflect the agency’s attempt to better align its definition of non-device software with the often misunderstood and misinterpreted statutory definition of CDS in section 520(o)(1)(E) of the Cures Act. The chart below summarizes the key provisions and changes to these guidance documents.

Digital health products can present a particular challenge for developers and regulators in assessing the appropriate regulatory pathways for a new product. The updated guidance documents reflect the need for a more flexible, risk-based approach to regulation that accommodates a rapidly evolving technological landscape. These documents also reflect what appears to be the new normal for digital health regulation—the need for iterative thinking and ongoing revisions to interpretive guidance documents to keep pace with a constantly changing marketplace.

Click here to read the full client alert on this issue. 




ONC Sends Information Blocking Proposed Rule to OMB

The Office of the National Coordinator for Health Information Technology (ONC) is one step closer to issuing its long-awaited proposed rule to implement various provisions of the 21st Century Cures Act, including proposed regulations distinguishing between prohibited health information blocking among health care providers and health information technology vendors and other permissible restrictions on access to health information. According to its website, the Office of Management and Budget (OMB) received ONC’s proposed rule for review on September 17, 2018. OMB review is one of the final steps in the process before a proposed rule is published in the Federal Register for public comments. OMB did not identify a deadline for completing its review. The agency generally has up to 90 days to complete its review, but can take less time than that.

In addition to defining the scope of prohibited information blocking conduct, the proposed rule is likely to address other issues of interest to health industry stakeholders. According to OMB, the proposed rule “would update the ONC Health IT Certification Program (Program) by implementing certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (IT) developers, the voluntary certification of health IT for use by pediatric healthcare providers, health information network voluntary attestation to the adoption of a trusted exchange framework and common agreement in support of network-to-network exchange, and reasonable and necessary activities that do not constitute information blocking. The rulemaking would also modify the Program through other complementary means to advance health IT certification and interoperability.”

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On the Digital Health Frontier: Developments Driving Industry Change in 2018

As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to changing the landscape for product research, development and commercialization. Modernization of the existing legal framework has not kept pace with the rate of digital health innovation, leaving no shortage of obstacles, misalignment and ambiguity for those in the wake.

What did we learn in 2017 and what’s to come on the digital health frontier in the year ahead? From advances and investments in artificial intelligence (AI) and machine learning (ML) to the increasingly complex conversion of health care innovation and policy, McDermott’s Digital Health Year in Review details the key developments that shaped digital health in 2017, along with planning considerations and predictions for the health care and life science industries in 2018.  (more…)




FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program

Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency plans to explore an innovative approach to regulating these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification Program and (3) an internal expansion of FDA’s digital health capabilities.

The webinar was presented by Bakul Patel, Associate Director for Digital Health at FDA. At least 905 attendees logged in to the webinar. (more…)




More Federal Legislation Aimed at Expanding Medicare Coverage of Telehealth Services

Late last month, Senator Cory Gardner (R-CO) and Senator Gary Peters (D-MI) introduced Senate Bill 787, the Telehealth Innovation and Improvement Act (Telehealth Improvement Act), which is focused on expanding Medicare’s currently limited coverage of telehealth services and opportunities for innovation.

The Telehealth Improvement Act would require the Center for Medicare and Medicaid Innovation (CMMI) to test the effect of including telehealth services in Medicare health care delivery reform models. More specifically, the Act would require CMMI to assess telehealth models for effectiveness, cost and quality improvement, and if the telehealth model meets these criteria, then the model will be covered through the Medicare program. (more…)




End of Year Attention to Health IT and Digital Health Tools in 21st Century Cures

On December 7, 2016, the US Congress approved the 21st Century Cures Act (Cures legislation), which is intended to accelerate the “discovery, development and delivery” of medical therapies by encouraging public and private biomedical research investment, facilitating innovation review and approval processes, and continuing to invest and modernize the delivery of health care. The massive bill, however, also served as a vehicle for a variety of other health-related measures, including provisions relating to health information technology (HIT) and related digital health initiatives.  President Barack Obama has expressed support for the Cures legislation and is expected to sign the bill this month.

The HIT provisions of the Cures legislation in general seek to:

  • Reduce administrative and regulatory burdens associated with providers’ use of electronic health records (EHRs)
  • Advance interoperability
  • Promote standards for HIT
  • Curb information blocking
  • Improve patient care and access to health information in EHRs

As public and private payers increasingly move from fee-for-service payments to value-based payment models, with a focus on maximizing health outcomes, population health improvement, and patient engagement, HIT—including EHRs and digital health tools—will be increasingly relied upon to collect clinical data, measure quality and cost effectiveness; assure continuity of care between patients and providers in different locations; and develop evidence-based clinical care guidelines.

Read the full article.




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