Healthcare AI faces a growing and sometimes unclear set of regulatory requirements. Compliance counsel acts as an advisor, helping healthcare organizations understand and comply with these rules to avoid legal and operational issues.
Rebecca K. Wood, a former Chief Counsel at the U.S. Food and Drug Administration (FDA) and current global co-leader of Sidley Austin LLP’s Food, Drug and Medical Device practice, illustrates the expertise needed to handle FDA regulatory matters related to digital health and AI. She has advised on topics such as device approvals, clinical trial regulations, and compliance enforcement, showing the importance of legal counsel in navigating AI in healthcare.
AI technologies used in medical devices and digital health platforms must comply with FDA standards on safety, effectiveness, and regulation. Counsel support clients in interpreting both long-established rules and new guidelines aimed at AI algorithms, machine learning models, and other software tools. These regulatory guidelines are still developing, which creates uncertainty requiring careful interpretation and active risk management.
Beyond FDA oversight, compliance counsel also deals with privacy laws like the Health Insurance Portability and Accountability Act (HIPAA), data security rules, and state regulations that govern AI use in healthcare. These overlapping laws require coordinated legal strategies to make sure AI use does not accidentally expose patient information or violate consent rules.
The use of AI in healthcare introduces potential liability issues. If AI-driven systems fail to work as expected, it can cause medical errors, affect patient safety, and lead to lawsuits.
Legal counsel helps medical practices build compliance programs that reduce these risks. This can involve setting vendor qualification standards, performing risk assessments before using AI tools, and keeping documentation to show adherence to regulatory and ethical standards.
Rebecca Wood’s experience with multidistrict litigation, federal preemption, and complex compliance reviews serves as an example of how counsel can handle difficult cases when AI-related medical products face legal challenges. Her knowledge of federal removal and jurisdiction is especially useful for clients dealing with class-action or multi-plaintiff lawsuits from AI failures or data breaches.
Despite regulatory challenges, AI offers clear benefits in healthcare operations and patient services. Tasks such as scheduling, patient communication, and data entry can be automated to ease staff workload and reduce costs.
The AHIMA Virtual AI Summit in 2025 focused on non-clinical AI uses, showing that AI is becoming an important part of healthcare operations. Speakers noted that AI helps automate routine tasks, simplify workflows, and increase productivity.
Kelly Canter, a healthcare information and AI technology expert, pointed out that these AI tools bring measurable improvements by streamlining procedures, removing bottlenecks, and cutting costs, particularly for small to medium medical practices aiming for greater efficiency without lowering care quality.
Ammon Fillmore, an advisor on AI privacy and security, discussed ethical issues and compliance structures vital to safe AI use. He stressed the need for governance policies that protect patient rights while enhancing operational benefits.
One important AI application for compliance counsel and healthcare managers involves automating front-office tasks and patient communication. Simbo AI, for example, offers AI-based front-office phone automation and answering services tailored to medical offices.
AI phone systems can manage appointment bookings, reminders, insurance checks, and even patient triage using natural language processing. This lowers the number of calls needing staff attention, letting medical teams concentrate on clinical and administrative duties that require human judgement.
Megan Pruente, MPH and health information expert, explained how large language models behind AI phone assistants reduce administrative difficulties by accurately understanding patient questions and providing prompt answers. This “digital teammate” effect boosts productivity without sacrificing accuracy or professionalism.
Rachel Podczervinski, an advocate for responsible AI use, noted that AI systems also improve patient data management by fixing problems like patient matching errors and data governance issues. This leads to cleaner records, better billing accuracy, and less administrative rework.
In the U.S. healthcare system, where privacy and compliance laws are strict, workflow automation must be implemented securely and with auditability. Compliance counsel has a key role in reviewing AI vendors such as Simbo AI to ensure solutions follow HIPAA requirements and maintain organizational compliance during rollout.
The AHIMA Virtual AI Summit emphasized the need to increase AI knowledge among healthcare information professionals. David Marc, PhD, CHDA, described workforce development as a crucial step for successful AI adoption in healthcare.
Healthcare organizations should train their staff, including practice administrators and IT personnel, to grasp AI fundamentals, ethical issues, and practical deployment challenges. Continuous education supports operational efficiency and compliance since informed teams manage AI governance and reporting better.
Working alongside compliance counsel, healthcare managers can create AI governance plans that include staff training, documentation protocols, and procedures for handling incidents.
Using AI responsibly in healthcare requires a solid governance framework that matches legal, ethical, and operational standards. Ammon Fillmore’s AHIMA presentation emphasized that governance goes beyond regulatory compliance. It involves ongoing oversight of AI tools to manage risk, prevent bias, and maintain transparency.
For medical practices in the U.S., governance means policies for validating algorithms, routinely auditing AI results, informing patients about AI’s role, and quick processes for addressing errors or complaints. Compliance counsel assists in drafting and reviewing these documents to help organizations meet both federal and state regulations.
Regulations around AI in healthcare continue to change. Agencies like the FDA are updating rules for digital health and AI-based medical devices. Counsel such as Rebecca Wood help shape these developments by advising stakeholders on regulatory expectations and best practices.
Medical executives and IT managers must keep up with new guidance and emerging rules to stay compliant and competitive. Working closely with compliance counsel allows organizations to react effectively to regulatory updates, litigation risks, and compliance audits.
By combining regulatory knowledge with operational planning, healthcare providers can use AI solutions knowing that risks are controlled and legal duties are met.
Compliance counsel plays an important role in the advancement of AI technologies in healthcare across the United States. They help medical practices handle regulatory demands, litigation risks, ethical governance, and workforce training, all essential for effective AI use.
AI-driven automation tools, like those from companies such as Simbo AI, provide practical applications that reduce administrative tasks and improve operational efficiency. With proper legal oversight and compliance management, healthcare organizations can adopt these technologies within a secure and regulated framework, benefiting both patients and providers.
Rebecca Wood is the global co-leader of Sidley Austin LLP’s Food, Drug and Medical Device practice and leads the Washington, D.C. Healthcare and FDMD group, providing counsel on FDA regulatory and compliance issues.
She handles FDA regulatory matters, compliance issues, impact litigation, and FDA supervisory reviews related to biotechnology, medical devices, and AI technologies.
She served as Chief Counsel to the FDA, advising on major initiatives, including drug and device approval processes and regulatory framework modernization.
She has navigated clinical holds for gene therapies, OAI inspection designations for medical devices, and assisted biotech firms in significant FDA meetings.
Her experience at the FDA provides her with unique insights into regulatory environments and the challenges her clients face.
She has been recognized by Chambers USA and LMG Life Sciences for her expertise in life sciences regulatory compliance and healthcare law.
She supports biotech and medical device firms in understanding FDA regulations specifically related to digital health and AI technologies.
Her pro bono efforts involve representing various legal associations and contributing to significant litigation cases, including appeals and compensation challenges.
Rebecca holds a J.D. from New York University School of Law and a B.A. from Yale University, graduating magna cum laude.
Clients describe her as responsive, pragmatic, and strategic, valuing her ability to provide elegant solutions to regulatory challenges.
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