Software as Medical Device
“Software as a Medical Device” (SaMD) has been defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
What is needed to create and launch an SaMD?
- An organizational structure that provides leadership, accountability, and governance with adequate resources to assure the safety, effectiveness, and performance of SaMD
- A set of SaMD lifecycle support processes that are scalable for the size of the organization and are applied consistently across all realization and use processes; and
- A set of realization and use processes that are scalable for the type of SaMD and the size of the organization; and that takes into account important elements required for assuring the safety, effectiveness, and performance of SaMD
Be able to answer the following questions:
- Is there a valid clinical association between your SaMD output and your SaMD’s targeted clinical condition?
- Does your SaMD correctly process input data to generate accurate, reliable, and precise output data?
- Does use of your SaMD’s accurate, reliable, and precise output data achieve your intended purpose in your target population in the context of clinical care?
Cyber INCIDENT RESPONSE PLAN
If you have already created a Cyber Incident Response Plan, that is great, please make sure that you have included a step to contact and notify:
- Your FBI Field Office Cyber TaskForce www.fbi.gov/contact-us/field/field-offices immediately to report a cyber incident and request assistance. These professionals work with state and local law enforcement and other federal and international partners to pursue cyber criminals globally and to assist victims of cyber crime.
- US-CERT www.us-cert.gov/ncas and FBI’s Internet Crime Complaint Center www.ic3.gov