MedTech

Question 1

What does “MedTech” include?

Answer 1

• x-ray/MRI/CT
• real time data collecting/monitoring
• at home testing (DNA/fertility/cancer)
• EHR accessibility

Question 2

What laws govern MedTech?

Answer 2

Section 5 of FTC
FDCA of FDA

Question 3

What is regulated by the governing laws?

Answer 3

Devices
–used to diagnose, treat or prevent disease/condition
– level of risk determines regulation
———most medtech = low risk

Software as a medical devices
– AI enabled

Cybersecurity
– FDA may reject devices due to poor cybersecurity protections

Question 4

State laws that deal with MedTech

Answer 4

AZ, CA, UT all have laws requiring transparency and express consent.