QUESTION

When should we consult with a lawyer regarding our healthcare startup?

SHORT ANSWER
The legal requirements governing healthcare businesses directly impact revenue and business models; so get advice early.
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Although it is always wise to consult with a lawyer early in the development of any new business, it is especially important in the healthcare industry. Starting a Med Spa or house call service? If any of the proposed services can be considered medical procedures, then statutes that prohibit non-physician ownership of medical providers might be an issue. What if you are simply taking a percentage of the fee for such procedures, which the doctor will perform? Many states prohibit physicians from splitting their fee. Ok, so what if you provide all the marketing and administrative support, while the doctors provide the medical services (i.e., you form a Managed Service Organization)? You better ensure the MSO justifies its revenue for such services without violating the federal Anti-Kickback Statute.

Even healthcare startups that do not deal directly with patients must navigate these regulations. Developing a patient data app? Review HIPAA to make sure that such data is accessible, and that you can use it the way you are intending. Providing medical supplies and equipment to physicians and  healthcare facilities? Your sales model needs to comply with applicable regulations. And of course, if physicians own or invest in the business, the federal Stark Law (and related state statutes) will come into play.

None of this is to say that the legal requirements for a healthcare startup cannot be met. Entrepreneurs prove otherwise every day. But it does mean that fleshing out the business model is often an iterative process in which a lawyer should be a key player.