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The Next Wave: Federal Regulatory, Intellectual Property, And Tort Liability Considerations For Medical Device Software, 2 J. Marshall Rev. Intell. Prop. L. 259 (2003), Paul A. Mathew
UIC Review of Intellectual Property Law
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 …