Laws & regulations surrounding the evolution ofTelemedicine<br />Presented by Lynne Watanabe<br />
Story of my 77 yr old awesome mom!<br />The rising elderly population <br />140 million have chronic disease.<br />80% hav...
Benefits to Telemedicine<br />Improved Access<br />Cost Efficiencies <br />Patient Demand ‐  Using telemedicine technologi...
Components of telemetry<br />Display<br />Sensor<br />Computer<br />Transmission<br />Sensors are regulated by the FDA<br ...
Convergence of technologies<br />Smartphones<br />Mobile Apps<br />Different networks:<br /> Sensors with networks (Zi...
Good! <br />FCC regulates healthcare bandwidth<br />And provides MBAN dedicated bandwidth<br />
Good! <br />
Benefits of a Broadband Healthcare Network<br />-Clinical care<br />-Consumer and professional health education<br />-Publ...
BAD! <br />ATA Smack Down of FCC’s Rural Health Care Pilot Program<br />Promised $400 million annually, but only received ...
FDA regulates devices…<br />The FDA regulates drugs & medical devices<br />But thousands of devices go through an expedite...
FCC and FDA to work on effective mHealthregulation<br />The FCC wants FDA to collaboratively work on regulatory clarific...
“People need to be assured that their health records are secure and private.<br /> I feel equally strongly that conversi...
Privacy, confidentiality & security <br />HIPAAwas created to streamline electronic medical records (EMR) while protecting...
Who must follow HIPAA?<br /> Health Plans<br /> Health Care Providers Health Care Clearinghouses<br />
First Civil penalty levied under the HIPPA Law: 41 patients could not access files<br />The civil rights office fined a Ma...
“People say they are afraid that if their private information becomes known, they may not be able to get health insurance...
Who Is Not Required to Follow HIPAA Laws<br />life insurers<br />employers<br />workers compensation carriers<br />many s...
Are you worried about LULZSec or Anonymous coming after your health stats; hacking the Cloud?<br />
No!Don’t blame the Cloudlook at theFACTS.<br />
“Wall of Shame” – HHS.gov(HITECH Act)<br />281HIPAA violations that affected more than 500 individuals ( June 9, 2011)<b...
Docs love eHealth apps…but<br /> Within the past 2 years, personal health information of 1.9 million patients has been exp...
Regulatory Issues<br />Cross-border/Interstate telemetry litigation<br /> If CARE is determined to occur at the LOCATION O...
Telemedicine challenges state registration/license of practitioners<br />Washington state has no rules or laws on telemedi...
Do you feel safer and are you willing to risk your personal health records for convenience? <br />
Credits<br />Slide #5 & #11: http://arstechnica.com/science/news/2011/08/temporary-tattoo-electronics-flexible-ultrathin-m...
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Laws & regulations surrounding the evolution of Telemedicine

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Brief overview of the legalities surrounding the adoption of telemedicine and electronic medical records for MCDM Law Com 558 class. Twitter feed: #com558.

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  • Baby boomers are entering the retirement age. 80% of people over 65 have two or more chronic disease. 140 million have chronic disease. -There’s an increase demand for nurses and health care professionals. -Chronic diseases are the number one cause for expensive hospital visits.
  • Improved Access – For over 40 years, Bring healthcare services to patients in distant locations. Cost Efficiencies ‐ Reducing or containing the cost of healthcare is one of the most important reasons for funding and adopting telehealth technologies. Telemedicine has been shown to reduce  the cost of healthcare and increase efficiency through better management of chronic diseases,  shared health professional staffing, reduced travel times, and fewer or shorter hospital stays.    Patient Demand ‐ Consumers want telemedicine. Using telemedicine technologies reduces travel time and related stresses to the patient. 
  • Telemetry is the science/technology of collecting sensor data and transmitting it to a remote location.Remote Monitoring~ In essence, telemetry is having the ability to ‘see’ and sometimes control from far away.Sensor are regulated under FDATransmission is regulated by the FCC
  • All four technologies evolved separately but we’re seeing more convergence in Telemetry. We are seeing smartphones and ipads.Today’s health care environment is defined by dramatic change, extraordinary competition and rising regulatory complexity.Each have their own separate PATENTS &amp; INTELLECTUAL PROPERTY liability but this overview will touch on current legal implications as the evolution of telemedicine evolves.All of these sensor data and health record must be stored electronically in order for patients and health care providers to access seamlessly.http://arstechnica.com/science/news/2011/08/temporary-tattoo-electronics-flexible-ultrathin-measurement-devices.ars
  • http://www.engadget.com/2011/01/21/health-care-and-aeronautics-industries-agree-that-fcc-should-set/FCC dedicating bandwidth to remote monitoring MBAN is a part of the FCC&apos;s National Broadband Plan and purports to use short-length radio waves (not unlike Bluetooth) in the 2300 and 2400 MHz range to transmit physiological info to treating physicians -- as opposed to other patient monitors that use web-based communications. MBAN would initially be used in hospitals but could later find its way into residential use by employing home entertainment systems (Wii Fit integration, here we come!) to collect and transmit data.
  • 17th Meeting of the American Health Information Community (AHIC) November 13, 2007
  • Benefits of a Broadband Healthcare NetworkClinical care- Consumer and professional health education Public health Health administration Research Electronic health records
  • 2006 FCC launched Rural Health Care Pilot program
  • http://www.chicagotribune.com/business/chi-medical-devices,0,238119.storyFind the case: premeeie baby was given overdose of medication because the nurse entered the wrong number.
  • The FCC recommended that it work together with the FDA to clarify regulatory requirements and the approval processes for converged communications and health care devices. The FCC specifically pointed to mobile health apps, smartphone remote monitoring apps, point of care diagnostic smartphone apps and wearable, wireless biometric sensors as examples of the products in need of regulatory clarification.http://mobihealthnews.com/6945/fcc-fda-to-work-on-effective-mhealth-regulation/
  • http://www.nytimes.com/2011/05/31/business/31privacy.html?pagewanted=1&amp;_r=2The adoption of telemedicine is dependent on the acceptance of EMR.Image: http://en.wikipedia.org/wiki/Kathleen_SebeliusIn order to guarantee patient security, privacy and confidentiality they created HIPPA to streamline the process of create EMR. The adoption of EMR (which involves telehealth) is critical.
  • As the technologytelehealth evolves, the concerns continue to grow. Your health information is protected under federal law. The Privacy Rule, a Federal law, gives you rights over your health information and sets rules and limits on who can look at and receive your health information. The Privacy Rule applies to all forms of individuals&apos; protected health information, whether electronic, written, or oral. The Security Rule, a Federal law that protects health information in electronic form, requires entities covered by HIPAA to ensure that electronic protected health information is secure.http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.htmlEMRs have had their share of problems…
  • http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.htmlImage: http://www.flickr.com/photos/clevercupcakes/4576733748/sizes/m/in/photostream/Health Plans, including health insurance companies, HMOs, company health plans, and certain government programs that pay for health care, such as Medicare and Medicaid.Health Care Providers—those that conduct certain business electronically, such as electronically billing your health insurance—including most doctors, clinics, hospitals, psychologists, chiropractors, nursing homes, pharmacies, and dentists. Health Care Clearinghouses—entities that process nonstandard health information they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa.
  • This is an example of a case where the health insurance denied patient’s right to view their own records. As per report, Cignet Health of Prince George&apos;s County Md. has been charged a whopping $4.3 million as civil money penalty (CMP) for denying accessibility to 41 patients to their medical records. Further it was also alleged that Cignet assumed a non co-operative stance willfully as it did not furnish the records when demanded by the Office for Civil Rights (OCR). Many a times organizations become victims of security breaches as they are incapable of purchasing new infrastructure that could help them remain compliant with the new and updated regulations. Most of them face massive pressures as they struggle to cope with revised and updated regulations while trying to maintain control over their budgets.Read more: http://www.articlesbase.com/security-articles/cignet-pays-a-heavy-price-for-hipaa-violation-4322603.html#ixzz1V2JGjTLHUnder Creative Commons License: Attribution No Derivativeshttp://www.articlesbase.com/security-articles/cignet-pays-a-heavy-price-for-hipaa-violation-4322603.html
  • http://healthit.hhs.gov/portal/server.pt/community/organizational_description_/1249/farzad_mostashari,_md,_scm/18220People are worried if there’s a breach of security they may not get health insurance.
  • Theydo not have to follow the Privacy and Security Rules!
  • http://www.softwareadvice.com/articles/medical/hipaa-violations-arent-in-the-cloud-1062011/
  • Known as the “Wall of Shame,” the HHS website details 281 Health Insurance Portability and Accountability Act (HIPAA) security violations that affected more than 500 individuals as of June 9, 2011.
  • Overall, physical theft and loss accounted for about 63% of the reported breaches. Unauthorized access / disclosure accounted for another 16%, while hacking was only 6%.Read more: http://www.softwareadvice.com/articles/medical/hipaa-violations-arent-in-the-cloud-1062011/#ixzz1UxtsenB6The vast majority of HIPAA violations weren’t instances of professional hacking –Most were a result of poor internal security, petty theft, or negligence. Don’t blame the Cloud!Carelessness, Theft to Blame for HIPAA Violations
  • http://www.mobilemarketingwatch.com/mobile-devices-increase-need-to-protect-phi-17248/
  • With the emergence of telemedicine, there is no clear law or body of knowledge to resolve the question of &quot;where does care occur&quot; when the patient and the provider are in different geographical locations. Is the care legally provided at the location of the patient or at the location of the provider? If care occurs at the location of the patient, is the nurse practicing telenursing expected to obtain a nursing license in every state where there might be electronic contact with a patient?If CARE is determined to occur at the LOCATION OF THE PROVIDER, how does the patient/consumer know where and how to SEEK RECOURSE in the event of SUBSTANDARD CARE or MALPRACTICEhttp://www.flickr.com/photos/europedistrict/3899824475/sizes/z/in/photostream/
  • http://www.doh.wa.gov/hsqa/mqac/internet.htm

    • Laws & regulations surrounding the evolution of Telemedicine

    1. 1. Laws & regulations surrounding the evolution ofTelemedicine<br />Presented by Lynne Watanabe<br />
    2. 2. Story of my 77 yr old awesome mom!<br />The rising elderly population <br />140 million have chronic disease.<br />80% have 2 or more chronic diseases<br />
    3. 3. Benefits to Telemedicine<br />Improved Access<br />Cost Efficiencies <br />Patient Demand ‐  Using telemedicine technologies reduces travel time and related stresses to the patient. <br />
    4. 4. Components of telemetry<br />Display<br />Sensor<br />Computer<br />Transmission<br />Sensors are regulated by the FDA<br />Transmission is regulated by the FCC<br />
    5. 5. Convergence of technologies<br />Smartphones<br />Mobile Apps<br />Different networks:<br /> Sensors with networks (Zigbee)<br /> WBAN & BAN (wireless) Body Area Networks<br />Cloud computing for EMRs<br />
    6. 6. Good! <br />FCC regulates healthcare bandwidth<br />And provides MBAN dedicated bandwidth<br />
    7. 7. Good! <br />
    8. 8. Benefits of a Broadband Healthcare Network<br />-Clinical care<br />-Consumer and professional health education<br />-Public health<br />-Health administration Research<br />-Electronic health records<br />FCC.gov<br />
    9. 9. BAD! <br />ATA Smack Down of FCC’s Rural Health Care Pilot Program<br />Promised $400 million annually, but only received 80 million this year.<br />www.fcc.gov/our-work.<br />
    10. 10. FDA regulates devices…<br />The FDA regulates drugs & medical devices<br />But thousands of devices go through an expedited review because they are considered similar to older devices that are already on the market.<br />Institute of Medicine, an arm of the National Academy of Sciences, recommended that the system be abolished and new procedures established.<br />
    11. 11. FCC and FDA to work on effective mHealthregulation<br />The FCC wants FDA to collaboratively work on regulatory clarifications with mobile health apps, smartphone remote monitoring apps, and wearable, wireless biometric sensors.<br />
    12. 12. “People need to be assured that their health records are secure and private.<br /> 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.” <br />- Kathleen Sebelius, Secretary of Health and Human Services<br />
    13. 13. Privacy, confidentiality & security <br />HIPAAwas created to streamline electronic medical records (EMR) while protecting patients. (1996)<br />
    14. 14. Who must follow HIPAA?<br /> Health Plans<br /> Health Care Providers Health Care Clearinghouses<br />
    15. 15. First Civil penalty levied under the HIPPA Law: 41 patients could not access files<br />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.<br />
    16. 16. “People say they are afraid that if their private information becomes known, they may not be able to get health insurance.”<br />- Dr. FarzadMostashari, National Coordinator for Health Information Technology<br />On the road to adoption of EMR…<br />
    17. 17. Who Is Not Required to Follow HIPAA Laws<br />life insurers<br />employers<br />workers compensation carriers<br />many schools & school districts<br />many state agencies like child protective service agencies<br />many law enforcement agencies<br />many municipal offices<br />
    18. 18. Are you worried about LULZSec or Anonymous coming after your health stats; hacking the Cloud?<br />
    19. 19. No!Don’t blame the Cloudlook at theFACTS.<br />
    20. 20. “Wall of Shame” – HHS.gov(HITECH Act)<br />281HIPAA violations that affected more than 500 individuals ( June 9, 2011)<br />
    21. 21.
    22. 22. Docs love eHealth apps…but<br /> Within the past 2 years, personal health information of 1.9 million patients has been exposed <br />- Office of Civil Rights<br />116 data breaches of over 500 records due to the theft of loss of mobile devices.<br />AirStrip Technologies' AirStrip Cardiology<br />
    23. 23. Regulatory Issues<br />Cross-border/Interstate telemetry litigation<br /> 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<br />
    24. 24. Telemedicine challenges state registration/license of practitioners<br />Washington state has no rules or laws on telemedicine…<br />but they have general guidelines<br />
    25. 25. Do you feel safer and are you willing to risk your personal health records for convenience? <br />
    26. 26. Credits<br />Slide #5 & #11: http://arstechnica.com/science/news/2011/08/temporary-tattoo-electronics-flexible-ultrathin-measurement-devices.ars<br />Slide #6: http://www.engadget.com/2011/01/21/health-care-and-aeronautics-industries-agree-that-fcc-should-set/<br /> Slide #7: 17th Meeting of the American Health Information Community (AHIC) November 13, 2007<br />Slide #8: http://www.mobilemarketingwatch.com/mobile-devices-increase-need-to-protect-phi-17248/<br />Slide #9: www.fcc.gov/our-work.<br />Slide #12: http://en.wikipedia.org/wiki/Kathleen_Sebelius<br />Slide #14: http://www.flickr.com/photos/clevercupcakes/4576733748/sizes/m/in/photostream/<br />Slide #16: http://healthit.hhs.gov/portal/server.pt/community/organizational_description_/1249/farzad_mostashari,_md,_scm/18220<br />Slide #18: http://www.softwareadvice.com/articles/medical/hipaa-violations-arent-in-the-cloud-1062011/<br />Slide #19: Sad Cloud by Nicole Cox<br />Slide #20: HHS.gov<br />Slide #21: http://www.softwareadvice.com/articles/medical/hipaa-violations-arent-in-the-cloud-1062011/#ixzz1UxtsenB6<br />Slide #22: Airstrip Technologies<br />Slide #23: http://www.flickr.com/photos/europedistrict/3899824475/sizes/z/in/photostream/<br />Lynne Watanabe UW MCDM student<br />http://twitter.com/telehealth_mom<br />http://telehealth4family.wordpress.com/<br />

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