On October 30, 2023, President Joe Biden signed the first ever Executive Order (EO) that specifically directs federal agencies on the use and regulation of Artificial Intelligence (AI). A Fact Sheet for this EO is also available.
This EO is a significant milestone as companies and other organizations globally grapple with the trustworthy use and creation of AI. Previous Biden-Harris Administration action on AI have been guidance of principles (e.g., the AI Bill of Rights) or have been targeted guidance on a particular aspect of AI such as the Executive Order Addressing Racial ...
Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is obvious. But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI?
In the absence of a federal law directly aimed at regulating artificial intelligence (AI), the Federal Trade Commission (FTC) is seeking to position itself as one of the primary regulators of this emergent technology through existing laws under the FTC’s ambit. As we recently wrote, the FTC announced the establishment of an Office of Technology, designed to provide technology expertise and support the FTC in enforcement actions. In a May 3, 2023 opinion piece published in the New York Times entitled “We Must Regulate A.I. Here’s How,” Lina Khan, the Chairperson of the FTC, outlined at least three potential avenues for FTC enforcement and oversight of artificial intelligence technology.
On February 17, 2023, the Federal Trade Commission (“FTC”) announced the creation of the Office of Technology (the “OT”), which will be headed by Stephanie T. Nguyen as Chief Technology Officer. This development comes on the heels of increasing FTC scrutiny of technology companies. The OT will provide technical expertise and strengthen the FTC’s ability to enforce competition and consumer protection laws across a wide variety of technology-related topics, such as artificial intelligence (“AI”), automated decision systems, digital advertising, and the collection and sale of data. In addition to assisting with enforcement matters, the OT will be responsible for, among other things, policy and research initiatives, and advising the FTC’s Office of Congressional Relations and its Office of International Affairs.
The success of an artificial intelligence (AI) algorithm depends in large part upon trust, yet many AI technologies function as opaque ‘black boxes.’ Indeed, some are intentionally designed that way. This charts a mistaken course.
Artificial Intelligence (“AI”) applications are powerful tools that already have been deployed by companies to improve business performance across the health care, manufacturing, retail, and banking industries, among many others. From largescale AI initiatives to smaller AI vendors, AI tools quickly are becoming a mainstream fixture in many industries and will likely infiltrate many more in the near future.
But are these companies also prepared to defend the use of AI tools should there be compliance issues at a later time? What should companies do before launching AI tools ...
The application of artificial intelligence technologies to health care delivery, coding and population management may profoundly alter the manner in which clinicians and others interact with patients, and seek reimbursement. While on one hand, AI may promote better treatment decisions and streamline onerous coding and claims submission, there are risks associated with unintended bias that may be lurking in the algorithms. AI is trained on data. To the extent that data encodes historical bias, that bias may cause unintended errors when applied to new patients. This can result in ...
After a Congressional override of a Presidential veto, the National Defense Authorization Act became law on January 1, 2021 (NDAA). Notably, the NDAA not only provides appropriations for military and defense purposes but, under Division E, it also includes the most significant U.S. legislation concerning artificial intelligence (AI) to date: The National Artificial Intelligence Initiative Act of 2020 (NAIIA).
The NAIIA sets forth a multi-pronged national strategy and funding approach to spur AI research, development and innovation within the U.S., train and prepare an ...
Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and consolidation in 2020. These predictions for 2020 are largely based on the increasing confluence of the following three key “drivers” of health industry transformation that is substantially underway:
- The ongoing national imperative of reducing the cost of health care, via disease prevention and detection, and cost-effective, quality treatment, including more efficient care in ambulatory and retail settings;
- Extraordinary advances in technologies which enhance disease prevention, detection and cost-effective treatment (e.g., artificial intelligence (AI)-driven diagnosis and treatment, virtual care, electronic medical record (EMR) systems, medical devices, gene therapy, and precision medicine); and
- The aging baby-boomer population, with tens of millions of Americans entering into their 70s, 80s, and above.
On October 22, 2019, the Centers for Medicare and Medicaid Services (“CMS”) issued a Request for Information (“RFI”) to obtain input on how CMS can utilize Artificial Intelligence (“AI”) and other new technologies to improve its operations. CMS’ objectives to leverage AI chiefly include identifying and preventing fraud, waste, and abuse. The RFI specifically states CMS’ aim “to ensure proper claims payment, reduce provider burden, and overall, conduct program integrity activities in a more efficient manner.” The RFI follows last month’s White House ...
The healthcare industry is still struggling to address its cybersecurity issues as 31 data breaches were reported in February 2019, exposing data from more than 2 million people. However, the emergence of artificial intelligence (AI) may provide tools to reduce cyber risk.
AI cybersecurity tools can enable organizations to improve data security by detecting and thwarting potential threats through automated systems that continuously monitor network behavior and identify network abnormalities. For example, AI may offer assistance in breach prevention by proactively ...
As stakeholders, legislators and policymakers wrestle with the myriad of issues related to the provision of remote health care, clinical and technological advancements continue apace. What was once an industry focused primarily on the provision of primary care through existing remote platforms is morphing into a highly sophisticated brew of clinical and technological innovation. In that regard, several trends have caught my attention. While these trends may not squarely fall within the accepted definitions of “telehealth”, they are worth noting because they raise many ...
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