Activating Standardization Bodies Around Medical Apps

Transcription

1 Activating Standardization Bodies Around Medical Apps Michael J. Ackerman, Ph.D. Assistant Director High Performance Computing and Communications U.S. National Library of Medicine

2 The views and opinions expressed do not necessarily state or reflect those of the U.S. Government, and they may not be used for advertising or product endorsement purposes. 2

3 3 w w w. n l m. n I h. g o v

4 The Problem An app is developed in Malaysia, purchased from the itunes store located in the United States by a person located in Italy for use in Brazil. Current regulatory or certification agencies, FDA, FCC, ISO, CEN, etc., have cycle times that do not match with app development. 4

5 m-health The practice of medicine and public health, supported by mobile devices, such as smart phones and wireless connectivity, for health services and information. The use of mobile devices to support health related monitoring and self help activities. 5

6 Pew Research Center: Mobile Health 2012 November 8, % of smartphone owners gather health information on their phones. Latinos, African Americans, people between the ages of 18 49, or people who hold a college degree are more likely to gather health information via smartphone. 6 Health.aspx

7 Pew Research Center: Mobile Health 2012 November 8, % of cell phone owners say they send and receive text messages but only 9% say they receive health or medical text updates or alerts. Women between the ages of 30 and 64 are more likely to have signed up for health text alerts. 20% of smartphone owners have a health app. Exercise, diet and weight apps are the most popular. 7 Health.aspx

8 In the United States: Who is the regulator or certifier? Wireless devices Federal Communications Commission (FCC) Medical devices Food and Drug Administration (FDA) Wireless medical devices??? 8

9 9 FDA or FCC?

10 FCC m-health Task Force September 24, 2012 Goals: FCC should continue to play a leadership role in advancing mobile health adoption. The FCC should build on existing programs and link programs when possible in order to expand broadband access for healthcare. The FCC should continue efforts to increase capacity, reliability, interoperability, and RF safety of m-health technologies. 10

11 FCC m-health Task Force September 24, 2012 Goals: Federal agencies should increase collaboration to promote innovation, protect patient safety, and avoid regulatory duplication. Industry should support continued investment, innovation, and job creation in the growing mobile health sector. 11

12 FCC m-health Task Force September 24, 2012 Barriers & Opportunities: Patient (elderly & low-income) and provider (rural) access to broadband coverage Reimbursement for cost reducing e Care services ONC should include m-health and other health IT services in Meaningful Use (MU) Interstate licensing for physicians and nurses 12

13 FCC m-health Task Force September 24, 2012 Barriers & Opportunities: Are the most appropriate wireless technologies being used for the various medical use cases? How is the high concentration of wireless devices impacting communication reliability? Specific absorption rate testing Patient safety, privacy and security 13

14 FDA Guidance for Mobile Medical Applications September 25, 2013 Mobile medical apps that FDA will regulate: Provides diagnosis or clinical decision support Intended to be used as an accessory to a regulated medical device: Examples: Remote display of bedside monitors, ECG waveforms, and medical images; the control of devices such as a blood pressure cuff or an insulin pump; etc. Transforms a mobile platform into a regulated medical device: Examples: Apps that turn mobile devices into electronic stethoscopes, glucose meters, sleep monitors, electrocardiogram, measure tremors, analyze eye movements, diagnose balance disorders, treat acne, etc. 14

15 FDA Guidance for Mobile Medical Applications September 25, 2013 Mobile medical apps for which FDA will exercise discretion does not expect to regulate: Manage health status Help users self-manage without providing suggestions Examples: Manage weight or salt intake, calculating body-mass index, etc. Help document and communicate with health provider Provide simple tools to organize and track health information Examples: Data logs for allergies, obesity, heart disease, fitness, etc. 15

16 FDA Guidance for Mobile Medical Applications September 25, 2013 Mobile medical apps for which FDA will exercise discretion does not expect to regulate: Manage health status Coach patients on coping with disease Examples: Heart disease, high blood pressure, diabetes, fitness, etc. Provide access to health information Examples: Medical dictionaries, textbooks, data bases, web sites, etc. Enable interaction with PHR and EHR 16

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18 What is a medical device? A device or program which provides medical recommendations: Most smartphone apps require connectivity to a sensor in order to access information on which to base a decision Neither the sensor nor the smartphone app is a medical device, but the combination could become a medical device if the combination provides medical recommendations 18

19 The need for additional guidance The ability to discern the difference between: regulated disease claims; unregulated wellness claims. The ability to discriminate between: regulated accessories, software and hardware, to known medical devices; and software and hardware products that are simply part of the communication network. A tremendous number of apps are designed to help us live healthier lives, as opposed to managing disease. 19

20 OWLET Baby Vitals Monitor How does the Owlet Vitals Monitor work? The Smart Sock is worn by your baby as he/she sleeps. It collects heart rate, oxygen, and sleep data and sends it via Bluetooth 4.0 to the parent's smartphone. Your infant's data is then pushed to the cloud and is available to any internet connected device. Does Owlet guarantee my baby's safety? No. The Owlet Vitals Monitor is meant to help you be aware of possible indicators of danger, but your baby's safety is your responsibility. Is it a considered a medical device? No, this is not a medical device. This is for health and wellness 20 purposes only.

21 21 ZEO personal sleep coach

22 Heart Monitor Cardionet Holter 22

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25 25 Track your personal fitness - Fitbit

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27 Digestible RFID Pills Proteus Biomedical 27

28 28 SMS Apps for Telehealth Appointment reminders Monitoring chronic illnesses asthma, diabetes, chronic heart failure Health messages Medication reminders AIDS, elderly, diabetes Reporting laboratory test results Surveillance reporting tool SARS, avian flu, H1N1 flu Emergency alerting tool Personal Health Record (PHR) Questions, consultation Literature search

29 Outbound SMS Medline via SMS Inbound SMS Search carpal tunnel syndrome surgery vs. steroid randomized control trial Surgical decompression vs. local steroid injection in carpal tunnel syndrome: A one year prospective randomized open controlled clinical trial 29 Lypen, D. Arthritis and Rheumatology, February The bottom line : Over the short term local steroid injection is better than surgical decompression for the symptomatic relief of carpal tunnel syndrome. At one year local steroid injection is as effective as surgical decompression for symptomatic relief.

30 30 The Smart Home

31 Sphygmomanometer Blood pressure Pulse Digestible RFID Pills NETWORK Glucometer Blood sugar 31 Smart Band-Aids - Chemistry Bathroom Scale Weight Water loss/gain

32 p-health 32 IEEE Journal of Biomedical and Health Informatics, 17(5):cover, September 2013

33 Now just an app, without an external sensor, can turn a 33 smartphone into a medical device Apps are being developed which use existing smartphone sensors: Microphone to measure heart rate; Accelerometers to measure tremor. Smartphones are being developed which contain physiological sensors: EKG sensors. Does the app make a medical recommendation?

34 The Need For a Neutral Third Party An internationally recognized testing and certification body like Health on the Net (HON): At almost no cost. Do the developers care enough to pay? Business plan? Liability? Powel, AC, AB Landman, DW Bates, JAMA, doi: /jama, 3/24/

35 An example - Happtique Happtique helps providers and their patients integrate apps and digital health technologies into routine clinical care and daily health management. The non-profit Greater New York Hospital Association The for-profit Greater New York Hospital Association Ventures. In late February 2013, Happtique published final standards for its m-health Application Certification Program (HACP) that will serve as a "good housekeeping seal of approval" for mobile healthcare apps. HACP is designed to evaluate and certify m- Health apps for privacy, security and content. In June, Happtique announced a collaboration with the Association of American Medical Colleges (AAMC) and the Commission on Graduates of Foreign Nursing Schools to evaluate health apps. 35

36 36 The business plan: The Happtique website points out: There are more than 40,000 apps claiming to be for mobile health; 78 percent of smartphone users won t download apps they don t trust. Happtique's certification program charges app developers $2,500 to $3,000 per app, and can evaluate apps within 30 days. The certification program examines the apps for the following: Meets data security standards; Operates as intended; Protects user privacy; Contains credible content.

37 Results: In November 2013, the company certified its first batch of mobile health apps. Dec. 13, 2013: Happtique suspends the program, less than two weeks after it approved the first set of mobile health apps, when security issues were discovered in two apps it had certified as secure. It was a disappointing and embarrassing start to a program that was designed to boost physicians confidence in m-health apps to a point where they would feel comfortable prescribing them to patients. 37

38 The only way to predict the future is to invent it. Lister Hill Center National Center for Biomedical Communications Questions? 38