Healthcare & Longevity

Hart David Carson LLP acts for healthcare and life-sciences businesses across the sector: providers and provider groups, digital-health and telehealth platforms, diagnostics and device companies, biotech and therapeutics ventures, and the longevity and healthspan companies working at the newer edge of the field. We also act for the investors, family offices, and sponsors who back them. The common thread is a regulated activity where corporate structure, regulatory posture, and intellectual property all have to line up.

Depending on the activity, a matter can touch the FDA, federal and state health-privacy regimes such as HIPAA, fraud-and-abuse and anti-kickback frameworks, the FTC on health claims and advertising, and state licensing and corporate-practice rules, alongside the IRS and securities regulators on the transactional and capital side. We help clients identify which frameworks apply to their specific activities and, where a regulator is involved, we represent clients in matters before the SEC, the CFTC, and the IRS.

Since 2020, which places the firm among the earlier advisers in a field whose products mostly reach the market under rules written for something else. The FDA has not treated aging itself as a disease, so a compound sold to extend healthspan is a drug if its labeling says it treats or prevents a disease, and it can be sold as a dietary supplement only if its ingredients qualify and its claims stay within structure-function language with the required disclaimer. Clinic services answer to state medical boards instead. Our work is placing a business correctly on that map and keeping its marketing inside the lane it chose, since the agency reads the website before it reads the science.

Yes, and in a provider acquisition the regulatory diligence is most of the deal. The buyer inherits the seller's billing history, so a coding and claims audit sets the size of the escrow and the special indemnity. The change of ownership has to be reported to Medicare within 30 days, and state licenses and payor contracts each carry their own notice or consent terms, some triggered by signing rather than closing. Physician compensation arrangements are re-tested under Stark after closing, because the buyer's affiliations change the referral map. In diagnostics, device, and biotech investments the same discipline applies to the regulatory pathway and the IP chain, and we run the corporate and regulatory work as one file.

Yes. The usual shape is research or clinical operations in one country, the intellectual property held in another, and the financing vehicle in a third. Two things break if they are not planned early. The first is the IP assignment chain from a university or research institution, which often carries government rights or revenue-share terms that follow the patent into every later license. The second is data: clinical and genomic data leaving the UK or the EU needs a lawful transfer mechanism, and tissue carries consent terms that can limit its commercial use. We coordinate the structure as a whole and work with locally admitted counsel where a domestic license, approval, or filing is required.

By starting from the regulator's own rule for ambiguity, which is intended use. The FDA classifies a product by what its sponsor says it does, read from labeling, websites, and sales decks, so the first control is the marketing copy rather than the science. Where the FTC is the risk, a health claim needs competent and reliable scientific evidence before it is made, and a clinic's before-and-after testimonials are claims. Where no agency has spoken, we write a classification memo that records the reasoning and the date, so that when guidance arrives the company can show what it knew and what it chose. The file is the defense.