Product and ownership
Software licenses, development agreements, founder and contractor IP assignments, model-provider terms and ownership of improvements. We separate the technology you bring from what you develop for a particular customer.
Commercial terms
Pilots, enterprise agreements, implementation scope, service levels, liability allocation and procurement requirements. The contract should reflect the product you can deliver and support.
FDA questions
Intended use, product claims and individual software functions inform whether Food and Drug Administration (FDA) device oversight applies. We assess that question before treating a product as general-purpose software or a regulated medical device. FDA Digital Health Policy Navigator.
Who provides the care
Clinical-entity relationships, MSO agreements, clinician engagement terms and the allocation of operational responsibilities.
Professional requirements
For California physician services, we address licensure and telehealth consent questions under Medical Board guidance. Other professions and patient locations need their own analysis. Medical Board telehealth guidance.
The patient relationship
Service descriptions, enrollment terms, communications, record custody and transitions when a clinician or clinical partner leaves.
For the management relationship, see Healthcare Management & Services.
The service chain
Device suppliers, software providers, monitoring organizations and clinical practices may each promise something different. We align the agreements with who receives, reviews and acts on the information.
Changes to functionality
Adding alerts, recommendations or diagnostic claims can change the regulatory analysis. We review the proposed function and its intended users as part of the product decision. FDA software framework.
Payment assumptions
We examine the legal and contractual assumptions behind the model, including who bills for which service. A commercial forecast needs a separate review of any reimbursement premise it relies on.
Yes. Send the current draft, the product description and the terms under discussion. We can identify legal issues, propose revisions and agree on the scope of negotiation support.
No. Explain what the product does, who uses it and how information moves. Those facts help identify the right questions and the work needed to answer them.
