13 Dec 2022
Clinical Decision Support (CDS) Software Final Rule
Understand the FDA’s final guidance addressing clinical decision support (CDS) software. Software intended for medical diagnosis or treatment has historically been considered a medical device subject to FDA regulation. Find out what makes a CDS product a medical device regulated by the FDA.
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Draft a representation and warranty clause to protect your client in an M&A transaction involving a life sciences company.
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Research state telehealth/telemedicine services, payment, and professional licensing rules. Highlighted issues include definitions of telehealth and telemedicine, covered providers, provider licensing requirements, and payment rules for public healthcare programs and health insurance.
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