Tuesday, December 06, 2011

#mhs11 FDA regulations around medical devices and apps mHealth regulatory coalition recommendations

Notes from mhealth summit.
Today if you connect to a medical device you are a medical device.
Now everything is connected.
Medical device data is:
Conversion, transfer,
Active patient monitoring
Device control
Mobile medical apps guidelines. Three tier pyramid.
1. Connects to a medical device
2. Transforms the mobile device I'm to a medical device
3. algorithm that output a patient specific result
It is not:
Medical text books
Providing clinicians with training
General health and wellness apps
Automate general office operations
Generic aids eg. Word processor
Electronic health records

Manage weight = wellness
Manage obesity = disease
Latter is medical device
The middle group that is undetermined:
- automate common medical knowledge
- self manage their disease
- automate common clinicians diagnostic ad treatment tasks
The mHealth regulatory coalition proposes changes to FDA proposed rules for mobile medical apps.
This is what FDA proposed:
Type A - aid in the use of parent device. Class 1 device
Type B - extends intended use - same level as parent device
type C - created a new intended use - bass on new risk.
Framework needed more clarity
Near term solution:
Type A - general purpose - unregulated Type B- not reasonably expected to directly affect safety and effectiveness - class 1
Type C - changes fundamental intended use- based on new risk
Type D - regulated products that are not toe a-c. Same as connected device.
We need new classification regulations. Need to clearly define categories.
Propose software modularization - use standard desin principles to create functional independence and reduce inherent risk of discrete modules.
Other agencies like FAA have embraced modularization for regulatory purposes.
Consider evolution of technology. Redefine fda's original manufacturer definition:
1. Mobile medical app manufacturer
2. Mobile platform manufacturer
In 1. The distributor is excluded. Eg. ITunes apps store.
In 2. Component manufacturers are excluded. Their platform is produced with no intended use.
Medical device manufacturers are exactly that.
Don't regulate distributor and component manufacturer categories.
MRC suggests: 1. Promoting investment and innovation
2. Clarify scope of FDA jurisdiction
3. Recognize current approach is an intrusion on the practice of medicine.
4. Recognize global nature and harmonization of regulation
5. Create an mHealth division in CDRH
6. Define regulatory state of EHR and HIE. 7. Consider CDS software software separately (clinical decision support)
Mark Scrimshire
B: http://ekive.blogspot.com
....Sent from my iPhone