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Balancing Privacy, Knowledge and Innovation @Omadahealth

Lucia C. Savage, JD

July 15, 2019, Washington DC

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INTRODUCTION

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Lucia

Savage

Chief Privacy and Regulatory Officer

Omada Health

  • Everyday, applying new facts to well-established laws and regulations to advance healthcare innovation
  • Urban gardener
  • Practicing law since before Al Gore invented the internet.

  • @savagelucia

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Omada Health: Bringing Human Connection to Digital Care

We connect people to health care professionals using secure digital systems and data science that engages individuals and delivers personalized healthcare

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The Patients have left the building, and Omada goes with them

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Mental

Health

Continued

Expansion...

Hypertension

Type 2 �Diabetes

Cardiovascular Risk

Prediabetes

Peer Influence

Connected Smart Devices

Dynamic Lessons

Action List �& Skills

Professional Health Coach

Coaching

Platform

Coach Tools

Participant Experience

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Data @Omadahealth

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01

Omada IS a covered entity under HIPAA--we provide health care services and bill w/an NPI, per regulations

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HITRUT and SOC2 Certified

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More than 250,000 individuals served

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Data Science makes our healthcare professionals smarter.

July 4, 2016 1:15 pm pdt

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Digital Data Omada Health Collects

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01

Name, DoB, Weight, Food, Health History

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Private Messages, group message board posts

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Activity trackers and HealthKit (through permission and APIs)

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Coming soon: Mental Health Assessments

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Medical device data connected with a unique IP address and other identifiers (again, using APIs)

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Narrative survey responses and interviews

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HOW DO WE DO IT?

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TRUST

Data Collection is for improving the individualized care we supply, just like at your doctor’s office

You can always, and easily, get your own data.

Privacy, Security, Transparency, Engagement

#ParticipantsFirst.

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Recommendations

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01

Pay digital health as a healthcare service under HIPAA

Privacy and Security automatically apply--45 CFR 160.103

Includes all the vendors for a digital health co. if they handle PHI. This raises all boats

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If digital health is not reimbursed as healthcare, no incentive to improve privacy and security

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If HIPAA does not apply (that is, digital health is not reimbursed as healthcare) then only FTC rules apply, says HHS to Congress.

https://www.healthit.gov/sites/default/files/non-covered_entities_report_june_17_2016.pdf

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Patients deserve the same set of privacy and security standards wherever, and however, they get healthcare. Id.

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Hold digital health to same standards as all other providers

Address program integrity concerns, if any, directly with industry

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Don’t wait to develop a digital health strategy

For the digitally adept and digital natives, digital healthcare is just healthcare

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