OF DIGITAL INTEREST
OF DIGITAL INTEREST
Legal news and analysis of all things digital
OF DIGITAL INTEREST
Legal news and analysis of all things digital
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US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence

by | Jan 17, 2020 | , , ,

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.

(more…)



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

by , , and | Oct 30, 2019 | ,

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.



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ONC Sends Information Blocking Proposed Rule to OMB

by | Sep 19, 2018 |

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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HHS Finalizes Overhaul of Federal Human Subjects Research Protections

by and | Jan 18, 2017 | , ,

On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.” These are the first revisions to the Common Rule since its original enactment in 1991, and have been in progress since HHS first published an Advanced Notice of Proposed Rulemaking in July 2011. According to the press release accompanying the final rule, HHS made “significant changes” to its most recent proposals (published in September 2015) in response to the 2,100+ public comments they received.

The majority of the Common Rule’s changes and new provisions will go into effect in 2018. We are reviewing the final rule in detail, and a summary of changes and new provisions is forthcoming.



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OMB Reviewing Common Rule Overhaul

by and | Jan 6, 2017 | , ,

On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB). These regulations, often referred to as the Common Rule, were originally developed in 1991 and have been adopted by multiple federal departments and agencies. OMB review is the last step before final publication and suggests that HHS is trying to release a final rule before President Obama leaves office on January 20, 2017.

Through its Office for Human Research Protections (OHRP), HHS initially published an Advanced Notice of Proposed Rulemaking in July 2011. The Advanced Notice generated significant controversy and OHRP did not publish a notice of proposed rulemaking (Proposed Rule) for over four years, ultimately doing so on September 8, 2015. The Proposed Rule, like its earlier Advanced Notice counterpart, suggested major changes to the Common Rule, including changes to its overall jurisdictional scope, requirements relating to secondary use of biospecimens and individually identifiable information, and the general research review and oversight process.

Since the Proposed Rule’s publication, OHRP has received significant feedback from both industry and expert advisory groups about the proposed changes and their overall impact. While certain proposed changes have been applauded, the Proposed Rule has also generated considerable concern and uncertainty among stakeholders.

The current status of OMB’s review is pending.



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