The time lag between technological innovation and the laws that would regulate it is especially pronounced with the advent of artificial intelligence (AI). As AI-based machine-learning applications proliferate in virtually every field, regulatory bodies have been hard put to keep up with the wide range of unprecedented issues they underscore. Companies looking to leverage these dynamic new technologies must tread carefully, combining self-regulation with savvy legal advice from lawyers thoroughly familiar with AI law and the pitfalls of operating in such an unsettled environment.
With its multidisciplinary capabilities and transactional, regulatory, and litigation experience, Epstein Becker Green is ideally suited to advise companies on how to reap the benefits of AI while minimizing its legal and business risks. Our attorneys have been witness to, and participants in, the rapid rise of AI. 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 AI 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.
Health Care Services and Reimbursement
While still in its infancy, AI has already brought an explosion of disruptive new technologies to the health care industry—with much more to come. Machine learning is transforming how diseases are predicted and managed, and how patients are diagnosed and treated. AI drives dramatic advances in robotic surgery, remote telehealth services, and smart hospital rooms. It also revolutionizes the administrative side of health care, particularly in the area of reimbursement.
Many of our clients are on the cutting edge of these advances, but the regulations they face raise more questions than answers in terms of how they comply. Old rules provide little guidance in the new context. These clients rely on Epstein Becker Green, a thought leader in the health care industry for more than 45 years, to help them develop AI-based products and steer these products through the approval processes of the Food and Drug Administration and other federal and state agencies. As existing payment schemes are reevaluated in light of AI-based services, we help clients navigate the new complexities of reimbursement from public and private payors.
In addition, our affiliates, EBG Advisors and National Health Advisors, are advising clients on numerous AI issues—addressing business strategy, policy analysis, data analytics, regulatory compliance, performance improvement, and payment/reimbursement for services and technology.
Disruption in the Workplace
There are few areas of labor and employment law that won’t eventually be touched by AI, and most already are. 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. In programming these tools, great care must be taken to keep them from perpetuating biases and stereotypes, so as to prevent exposure to discrimination claims.
We help clients handle the thorny issues that accompany machine-learning tools in the workplace. They turn to us to interpret the legal pitfalls of people analytics, digital interview platforms, chatbots, big data applications, and the like. 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. Once an AI-based product is implemented, we monitor and test it for legal red flags, and conduct ongoing evaluations as the usage evolves.
Data Privacy and Cybersecurity
AI applications are, by definition, huge consumers of data. Whether in the workplace, in the health care universe, or in any other field of endeavor, the flow of personal data into and out of machine-learning systems is as massive as it is fraught with privacy and cybersecurity issues. 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. And the collection of patient data through health-related devices and apps could give rise to violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Our clients have long trusted us to design effective compliance programs under existing laws, and they recognize that AI law compliance is a natural extension of our skills. We advise clients using AI on how to properly store and protect sensitive employee, patient, and personal data from unauthorized access by third parties or exposure through a breach. We also counsel clients on complying with both privacy laws when handling sensitive data needed for AI and cybersecurity laws and standards. In addition, clients seek our help in creating effective cybersecurity policies and vulnerability tests.
- Evaluated, on behalf of a major financial institution and a publishing company, an AI vendor for their employee recruitment, selection, and onboarding functions. We assisted our clients in assessing the product offerings, reviewing vendor contracts, identifying the appropriate questions to ask the vendors about their AI products, monitoring and testing those products, and evaluating whether those products would raise red flags from a legal perspective.
- Developed a comprehensive compliance plan for a health care company utilizing AI in billing and coding.
- Advised various employers regarding the consideration, adoption, and implementation of AI and predictive analytics in the workplace, particularly in HR communications and pay equity audits.
- Counseled all types of health care providers, including payors and pharmaceutical and device manufacturers, on regulatory requirements for our clients’ innovations in telemedicine and AI.
- Tested and monitored, on behalf of a transportation client, an AI software program that will be used to recruit and vet candidates in its HR department.
- Obtained new regulatory guidance for AI health technology companies by clarifying the FDA’s pathway to market for AI-based devices.
- Counseled numerous startup medical AI companies on marketing options and regulatory burdens.