Operator grounded opinions in healthcare compliance, hospital operations, FDA medical device regulatory frameworks, and healthcare finance. Engagements are accepted only through retaining counsel.
Three decades co-founding and running FDA regulated surgical hospitals, ambulatory surgical centers, clinical laboratories, and pharmacy operations inform this work. Opinions come from having built and run these businesses, not from theory.
Practical experience with the compliance frameworks that govern healthcare operating companies. This includes the federal physician self referral law (Stark Law), the Anti-Kickback Statute, and HIPAA as they arise in hospital and ancillary services operations, transactions, and day to day business practice.
Compliance program structure can be evaluated against published federal guidance, including the compliance resources of the U.S. Department of Health and Human Services Office of Inspector General. See the HHS OIG compliance resources.
Working knowledge of the regulatory frameworks that apply to medical devices, including the premarket notification (510(k)) pathway, the Quality System Regulation under 21 CFR Part 820, labeling, and postmarket obligations. This experience supports opinions on how device regulatory expectations intersect with hospital and laboratory operations.
Scientific questions, including emerging device based approaches such as targeted osmotic lysis as a field of study, are addressed against the peer reviewed literature rather than advocacy.
Formation, licensure, accreditation, and business practice for surgical hospitals and ambulatory surgical centers. This covers governance, staffing models, payer relationships, and the operating controls that distinguish a well run facility from one that is not.
Experience with the financial structure of healthcare operating companies across formation, operation, and disposition. This includes revenue cycle realities, cost structure, valuation context for transactions, and the financial controls that compliance programs rely on.
Opinions are offered to assist the trier of fact and are framed to meet the reliability standards courts apply to expert testimony. See Federal Rule of Evidence 702 at the Cornell Legal Information Institute.
Where opinions rely on published research, sources are identified so they can be checked. Relevant literature is available through PubMed at the National Center for Biotechnology Information.
See the source cited public record at The Andrew Hillman Record, and the advisory practice.
This page is informational and is not legal advice. It does not create an attorney client relationship, and no attorney client relationship is formed by contacting this site or by reading this page. Mr. Hillman is not an attorney and does not provide legal advice. Expert witness and consulting engagements are undertaken only with and through retaining counsel.
Tell us about the matter through your retaining counsel. Scope and conflicts are reviewed before any engagement.
Confirm Availability for Deposition Request Retention Terms (Counsel Only) Access CV & Vetted Case Histories