Laws & regulations surrounding the evolution of

Telemedicine

Presented by Lynne Watanabe

Story of my 77 yr old awesome mom!

The rising elderly population 140 million have chronic disease.80% have 2 or more chronic diseases

Benefits to Telemedicine

• Improved Access• Cost Efficiencies

• Patient Demand ‐ Using telemedicine technologies reduces travel time and related stresses to the patient.

Components of telemetry

Sensor

Transmission

Computer

Display

Sensors are regulated by the FDATransmission is regulated by the FCC

Convergence of technologies

• Smartphones• Mobile Apps• Different networks:

Sensors with networks (Zigbee)WBAN & BAN (wireless) Body Area

Networks• Cloud computing for EMRs

FCC regulates healthcare bandwidthGood!

And provides MBAN dedicated bandwidth

Good!

FCC.gov

Benefits of a Broadband Healthcare Network

-Clinical care -Consumer and professional health education -Public health -Health administration Research- Electronic health records

ATA Smack Down of FCC’s Rural Health Care Pilot Program

BAD!

Promised $400 million annually, but only received 80 million this year.

www.fcc.gov/our-work.

FDA regulates devices…

• The FDA regulates drugs & medical devices• But thousands of devices go through an

expedited review because they are considered similar to older devices that are already on the market.

• Institute of Medicine, an arm of the National Academy of Sciences, recommended that the system be abolished and new procedures established.

FCC and FDA to work on effective mHealth regulation

• The FCC wants FDA to collaboratively work on regulatory clarifications with mobile health apps, smartphone remote monitoring apps, and wearable, wireless biometric sensors.

“People need to be assured that their health records are secure and private.

I feel equally strongly that conversion to electronic health records may be one of the most transformative issues in the delivery of health care, lowering medical errors, reducing costs and helping to improve the quality of outcomes.”

- Kathleen Sebelius, Secretary of Health and Human Services

Privacy, confidentiality & security

HIPAA was created to streamline electronic medical records (EMR) while protecting patients. (1996)

Who must follow HIPAA?

Health Plans

Health Care Providers

Health Care Clearinghouses

First Civil penalty levied under the HIPPA Law: 41 patients could not access files

• The civil rights office fined a Maryland health plan, Cignet Health, $4.3 million, saying that it had denied patients the right to see their own records in violation of HIPAA provisions.

“People say they are afraid that if their private information becomes known, they may not be able to get health insurance.”

- Dr. Farzad Mostashari, National Coordinator for Health Information Technology

On the road to adoption of EMR…

Who Is Not Required to Follow HIPAA Laws

• life insurers• employers• workers compensation carriers• many schools & school districts• many state agencies like child protective

service agencies• many law enforcement agencies• many municipal offices

Are you worried about LULZSec or Anonymous coming after your health stats; hacking the Cloud?

No!

Don’t blame the Cloud

look at the FACTS.

“Wall of Shame” – HHS.gov(HITECH Act)

281 HIPAA violations that affected more than 500 individuals ( June 9, 2011)

Docs love eHealth apps…but

Within the past 2 years, personal health information of 1.9 million patients has been exposed - Office of Civil Rights

116 data breaches of over 500 records due to the

theft of loss of mobile devices. AirStrip Technologies'

AirStrip Cardiology

Regulatory Issues

• Cross-border/Interstate telemetry litigation

If CARE is determined to occur at the LOCATION OF THE PROVIDER, how does the patient know WHERE and how to SEEK RECOURSE in the event of SUBSTANDARD CARE or MALPRACTICE

Telemedicine challenges state registration/license of practitioners

Washington state has no rules or laws on telemedicine…

but they have general guidelines

Do you feel safer and are you willing to risk your personal health records for convenience?

Credits• Slide #5 & #11: http://arstechnica.com/science/news/2011/08/temporary-tattoo-electronics-flexible-

ultrathin-measurement-devices.ars• Slide #6: http://www.engadget.com/2011/01/21/health-care-and-aeronautics-industries-agree-that-fcc-

should-set/• Slide #7: 17th Meeting of the American Health Information Community (AHIC) November 13, 2007• Slide #8: http://www.mobilemarketingwatch.com/mobile-devices-increase-need-to-protect-phi-17248/• Slide #9: www.fcc.gov/our-work.• Slide #12: http://en.wikipedia.org/wiki/Kathleen_Sebelius• Slide #14: http://www.flickr.com/photos/clevercupcakes/4576733748/sizes/m/in/photostream/• Slide #16: http://healthit.hhs.gov/portal/server.pt/community/organizational_description_/1249/

farzad_mostashari,_md,_scm/18220• Slide #18: http://www.softwareadvice.com/articles/medical/hipaa-violations-arent-in-the-cloud-1062011/• Slide #19: Sad Cloud by Nicole Cox• Slide #20: HHS.gov• Slide #21:

http://www.softwareadvice.com/articles/medical/hipaa-violations-arent-in-the-cloud-1062011/#ixzz1UxtsenB6

• Slide #22: Airstrip Technologies• Slide #23: http://www.flickr.com/photos/europedistrict/3899824475/sizes/z/in/photostream/

Lynne Watanabe UW MCDM studenthttp://twitter.com/telehealth_mom

http://telehealth4family.wordpress.com/