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Health Tech Law & 'Software as Medical Device' (SaMD)

Miami - April 12, 2021

Health Technology means the application of organized knowledge and skills in the form of devices (standardized physical objects), medicines (e.g. pharmaceuticals and medicinal drugs), vaccines, procedures (traditional means and methods to treat and care for patients) and systems (designed social means and methods to treat and care for patients including computer-supported information systems e.g. health-related apps operated/marketed by private digital healthtech companies) developed to solve health problems (with actual diagnosis, treatment, prescription and cure or via the sharing of science-based health/medical information for outreach, educational, prevention, awareness-raising or treatment purposes) and improve life quality and physical and/or mental well-being of patients. [definition expanded from the World Health Organization's definition available at: ]

Such Health Technologies also include nowadays 'Software as Medical Devices' (SaMD(s)). A SaMD is defined by the International Medical Device Regulators Forum (IMDRF: as a software intended to be used for one or several medical purposes (e.g. diagnosis, cure, mitigation, treatment/prevention of disease or to affect the structure and/or function of the human body) and performing such purposes without being part of a hardware medical device for instance:

  • smartphone applications to view images obtained from Magnetic Resonance Imaging (MRI) medical device for diagnostic purposes, or
  • Computer-Aided Detection (CAD) software performing image post-processing to help detect tumors.

Thus, we can define 'Health Technology Law' as the body of laws and regulations (intersecting between Public Health and Personal/Private Health) governing the design/development, operation and use of health technologies (applying scientific medical knowledge to practical use) — including SaMDs — in connection with matters including (without limitation):

  • Health Technology's Copyright Protection and Patent Eligibility/Protection;

  • Medical/Health-related Notices/Disclaimers placed on medical devices or on healthtech web/mobile platforms;

  • Patients’ Personal Health Information (PHI) protection if such PHI is collected and/or processed by any Health Technology [e.g. in compliance with the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA), with the Australia's Privacy Act 1988 or with the Canada's Personal Information Protection and Electronic Document Act 2000 (PIPEDA)];

  • Registration Requirements and Rules of Approval [by Public Health Governing Body e.g. the U.S. Food & Drug Administration (FDA), the Department of Health Canada or Australia's Therapeutic Goods Administration (TGA)] applicable to Manufacturers and their HealthTech products;

  • HealthTech Quality for example:

- Safety and Effectiveness of SaMDs’ Installation and Operation, and

- SaMDs' Quality/Safety/Effectiveness Control Process;

  • HealthTech Manufacturers’ Obligations to report (e.g. on defect corrections made to a medical device) to the competent Public Health Governing Body.

Dr. Ariel Humphrey