Devices measuring people.
WHAT IS MEASURED
Activity and movement Heart rate Sleep Location, for safety Medication adherence Environmental conditions in facilities
WHAT THE CATEGORIES ARE
Consumer wellness devices Regulated medical devices
WHY THAT DISTINCTION MATTERS ABSOLUTELY
Medical devices are regulated, requiring approval, quality systems and clinical evidence.
WHAT DETERMINES THE CATEGORY
The claims made, more than the technology.
WHAT TO NEVER DO
Make medical claims for an unregulated device.
WHAT CONSUMER DEVICES MAY SAY
General wellness statements, carefully worded.
WHAT DATA SENSITIVITY DEMANDS
Health data protection, which is stricter than general personal data Encryption throughout Strict access control Clear consent
WHAT RELIABILITY DEMANDS
Devices people depend on must fail safely and visibly.
WHY
A silent failure in a safety device is worse than no device.
WHAT TO IMPLEMENT
Clear indication of device status Alerting when a device stops reporting Battery warnings well in advance
WHAT TO CONSIDER
That users may be older, unwell, or have limited technical ability.
WHAT THAT DEMANDS
Simplicity above all.
WHAT OBLIGATIONS APPLY
Medical device and health data regulation. Take advice before building anything in this area.
