David Haddad gave a presentation at Legal Hackers NYC on May 22nd, 2014 talking about his trials and tribulations about being FDA approved.

1. Legal Hackers
May 22, 2014

2. Growth in tools

3. Chronic disease is on the rise

4. An infinite number of questions about our health

5. Unlocking data to tell better patient stories

6. Open data format
Clinical face-value
Products

7. Enabling data prescription
1. Clinician prescribe data based on the metrics that matter to
them (e.g. 30 minutes of moderate activity, 5 days a week)
2. Patient syncs their favorite app or devices
3. Data from disparate apps are integrated, normalized,
analyzed and visualized to provide context between clinical
visits

9. A mobile health tool as a medical device
Is something that is:
1. Used as an accessory to a regulated medical device
2. Transforming a platform into a regulated medical device
“…intended for use in performing a medical device function (i.e.
for diagnosis of disease or other conditions, or the cure,
mitigation, treatment, or prevention of disease) it is a medical
device, regardless of the platform on which it is run.” (Page 8)

10. Enforcement discretion (page 16)
● Help patients self-manage their condition without providing
treatment or treatment suggestions (ex. coaching)
● Provide patients with simple tools to organize and track their
health information (ex. our product)
● Provide easy access to information related to patients’ health
conditions or treatments (ex. personal health record?)
● Help patients document, show, or communicate potential
medical conditions to health care providers (
● Automate simple tasks for health care providers
● Enable patients or providers to interact with Personal Health
Record or Electronic Health Record Systems.

11. My questions
1. We are “transforming” data to be actionable to a patient and
clinician. Not doing diagnostics, but providing insight that has
never been in a clinical visit. Where do we fit?
2. How do we handle devices that are regulated by the FDA?
Like an Omron Series 7 blood pressure cuff.
3. How do we develop language as part of our service
agreements with partners to ensure trust? Where should that
language live (online/in-app)? How do we ensure toolmakers’
T&A work?

12. Thanks
david@openmhealth.org / @haddadda
www.openmhealth.org