Counsel for the medical software technologist faces an unusually complex, ongoing, high-stakes challenge. Counsel operates in a special field of commercial, legal and regulatory forces: (1) intellectual property laws which govern the expression and protection of commercial rights derived from advances in medical science and technology; (2) existing and proposed contracts/warranty laws that govern technological commercial relationships; (3) negligence, professional liability, and product liability laws that govern the marketing of medical technologies; and, (4) a new body of regulation derived from the power of the federal government to indirectly provide for the safety, effectiveness, privacy, and security of medical technologies offered to the American public. Against that backdrop, the author provides an illustration of the commercialization of a new medical software technology and suggests a general approach to resolving the primary issues facing the medical software technologist.
Paul A. Mathew, The Next Wave: Federal Regulatory, Intellectual Property, and Tort Liability Considerations for Medical Device Software, 2 J. Marshall Rev. Intell. Prop. L. 259 (2003)