AI News, BOOK REVIEW: Global Summit on Regulatory Science

Artificial Intelligence

The time lag between technological innovation and the laws that would regulate it is especially pronounced with the advent of artificial intelligence (AI).

Companies looking to leverage these dynamic new technologies must tread carefully, combining self-regulation with savvy legal advice from lawyers thoroughly familiar with artificial intelligence law and the pitfalls of operating in such an unsettled environment.

We advise clients of all sizes—from Fortune 500 companies to small startups—on how to develop, leverage, and monetize these technologies and maintain a defensible compliance posture that stays attuned to evolving artificial intelligence laws and regulations.

And if clients face matters alleging AI-related harm (whether individual or class action cases or government enforcement actions), our litigators bring to bear the extensive trial experience necessary to build a successful defense or negotiate a favorable settlement.

From recruitment and hiring practices to human resources (HR) functions and to employee benefits design and administration, the opportunities to bring dazzling new tools into the workplace are matched only by their legal and ethical implications.

We counsel them on issues relating to unlawful discrimination, labor relations, wage and hour disputes, wearables in the workplace and accessibility, workplace data privacy and security, workplace transition policies, occupational health and safety, and the e-discovery of data collected by machines.

For example, the audio and video recording functionality of AI, as well as fingerprint, retina, and facial scanners, used for everything from access to a facility or room or time keeping to wellness program participation, may violate federal or state laws and regulations.

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Bradley Merrill Thompson

Brad Thompson counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.

Brad is a quantitative thinker by nature, who enjoys tinkering with algorithms.To develop a deeper understanding of machine learning algorithms, Brad has returned to the University of Michigan, part time and using distance learning avenues, to pursue a Masterin Applied Data Science from the School of Information.

In his own practice, Brad regularly advises developers of new “software as a medical device” (or “SaMD”) products seeking FDA approval through the de novo process, the 510(k) process, and even in tandem with drug products.

Throughout 2019, Brad visited eight of the leading engineering schools across the country to meet with students and alumni to teach them about the FDA requirements associated with bringing new AI-based medical device products to market.

Building on that momentum, Brad founded the AI Startups in Health Coalition (AISHC) to help ensure that startup companies addressing clinical needs have a voice in FDA’s future plans to regulate AI, including FDA’s policymaking on its software precertification program as well as its good machine learning practices initiative.

EBG Advisors is a network of international attorneys, regulatory affairs professionals, reimbursement experts, engineers, clinicians, quality systems advisors, and other professionals who specialize in providing coordinated guidance and solutions across various segments of the health care industry.

As Chief Data Scientist, in addition to working with clients bringing AI-driven medical products to market, Brad collaborates with other attorneys and consultants in such diverse areas as antitrust, employment law, and healthcare reimbursement, where data analysis plays a key role in successfully serving the client’s needs.

In the mid-1990s, on behalf of the IMDMC and about a dozen large trade associations representing virtually every industry the FDA regulates, Brad advocated that FDA should improve its guidance development process to enhance the quality and reliability of guidance as well as to better ensure public participation.

In legislative matters, Brad has over the years actively worked to ensure that health care economic information can be appropriately shared without running afoul of FDA requirements, and seeking to secure stakeholders a reasonable avenue of appeal when Medicare contractors deny claims.