m Health Roundup Apps for Consumers Providers Rita

m. Health Roundup Apps for Consumers & Providers Rita Sieracki, Medical College of WI Libraries

Are you fertile? Too sedentary? Need advance medical directives? Does this ankle need an x-ray? Want better heart health? Are you taking your meds?

There’s an app for that!

Almost two-thirds (66%) of Americans would use a mobile app to manage health-related issues. https: //www. itnonline. com/content/two-thirds-americans-favor-digital-personal-health-management 4

165, 000 m. Health apps – Apple & Google - 2015 5

Assessment of Consumer m. Health App Functionality 6

Top 5 Disease Specific Apps for 2015 Source: Mevvy, June 2015; IMS Institute for Health Care Informatics 7

More than 1/3 of physicians have recommended m. Health apps to patients Apps Prescribed by Providers 8

Source: Mevvy, June 2015; IMS Institute for Health Care Informatics 9

1, 761 articles in Pub. Med on m. Health Half have been published since 2016 10

Source: Mevvy, June 2015; IMS Institute for Health Care Informatics 11

372 clinical trials for m. Health in Clinical. Trials. gov 12

“Standard care with the addition of Mobile Thrive (M-Thrive), our innovative smart phone-based mobile app, is intended to demonstrate the clinical advantages of using mobile health technology (m. Health) in comparison to standard care alone. ” clinicaltrials. gov 13

Type of Smartphone App Clinical Trials Source: Clinical. Trials. gov; IMS Institute for Healthcare Informatics, August 2015 14

Makeup of Patients Enrolled in m. Health App Clinical Trials Source: Clinical. Trials. gov; IMS Institute for Healthcare Informatics, August 2015 15

Three tier risk-based approach used to assure safety and effectiveness of medical devices 16

Regulated Apps – Class III – High Risk • Control other devices • Display, store, analyze or transmit patient-specific medical data from another device • Use attachments, display screens, or sensors to transform the mobile platform into a medical device • Perform patient-specific analysis and provide patient specific diagnosis or treatment recommendation https: //www. fda. gov/Medical. Devices/Digital. Health/Mobile. Medical. Applications/ucm 255978. htm#b 17

Some Examples of Class III – High Risk Apps Mobile apps that: • use an attachment to the mobile platform to measure blood glucose levels. • analyze an image of a skin lesion using mathematical algorithms and provide the user with an assessment of the risk of the lesion. • alter the function or settings of an infusion pump. • control the inflation or deflation of a blood-pressure cuff. https: //www. fda. gov/Medical. Devices/Digital. Health/Mobile. Medical. Applications/ucm 255978. htm#b 18

Apps subject to enforcement discretion – Class II – Moderate Risk • Provide or facilitate supplemental care by coaching or prompting patients • Tools to help patients organize or track health information • Provide access to information related to health conditions or treatments • Allow patients to communicate medical conditions with providers • Perform simple calculations used in clinical practice • Enable individuals to interact with electronic health records https: //www. fda. gov/Medical. Devices/Digital. Health/Mobile. Medical. Applications/ucm 255978. htm#b 19

Some Examples of Class II – Moderate Risk Apps Mobile apps that: • provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women • keep track of medications and provide user-configured reminders for improved medication adherence • allow a user to collect, log, track, and trend data, such as blood glucose, blood pressure, heart rate, weight, or other data from a device to eventually share with a health care provider https: //www. fda. gov/Medical. Devices/Digital. Health/Mobile. Medical. Applications/ucm 255978. htm#b

Apps that will not be regulated – Class I – Low Risk • Electronic copies of medical textbooks, teaching aids, or other reference material • Intended as educational tools for medical training • Facilitate patient access or understanding • Automate general office operations • Not specifically designed or intended for medical purposes https: //www. fda. gov/Medical. Devices/Digital. Health/Mobile. Medical. Applications/ucm 255978. htm#b 21

Some Examples of Class I – Low Risk Apps • Electronic copies of medical textbooks or literature articles such as the PDR or DSM-IV • Encyclopedia of first-aid or emergency care information • Medical flash cards with medical images, pictures, graphs • Medical board certification or recertification preparation • Allow users to input pill shape, color, or imprint and displays pictures and names of pills that match this description https: //www. fda. gov/Medical. Devices/Digital. Health/Mobile. Medical. Applications/ucm 255978. htm#b 22

HIPAA The key to understanding whether HIPAA comes into play is understanding who is collecting the data, why the data are being collected, and who will use the data. 23

If a patient uses the app independently of a clinician’s advice and does not transmit any of the data collected by the app, it is likely that the app falls completely outside of the HIPAA realm When patients’ health information is in the possession of health providers, health plans, business associates, or other covered entities, it is protected under HIPAA also does not cover information on an individual’s mobile device. 24

Privacy 600 most common apps, • only 31 % had privacy policies at all required • reading level of such policies was typically at a college level • 66 % of these privacy policies consisted of legal “boilerplate” that did not even mention the specific app in question Glenn T, Monteith S. Privacy in the digital world: medical and health data outside of HIPAA protections. Curr Psychiatry Rep. 2014; 16(11): 494. 25

Healthcare-related data may be collected and sold by the app company for uses that the patient never imagined. Some patients may accept the tradeoff of privacy for the convenience or other services offered by the app, others will not. 88 percent of Americans would be willing to share their personal information for the sake of improving care and treatment options. Glenn T, Monteith S. Privacy in the digital world: medical and health data outside of HIPAA protections. Curr Psychiatry Rep. 2014; 16(11): 494. 26

Clinicians will find it important to educate patients about the potential lack of confidentiality associated with apps offering “treatment” outside of a healthcare setting governed by HIPAA. 27

American Medical Association • Consult attorney if you are unsure whether an m. Health app meets HIPAA standards • Ask about applicable state privacy & security laws The AMA will examine the potential liability risks to physicians for using, recommending or prescribing m. Health apps, including risk under federal and state medical liability, privacy and security laws. https: //wire. ama-assn. org/ama-news/high-quality-mhealth-apps-can-be-blended-care 28

Liability Questions • If an app provides inaccurate data that causes a clinician to mismanage a condition, how should liability be apportioned? • Additionally, if a patient makes mistakes in the use of an app and this results in mismanagement of her condition, to whom will blame ultimately be assigned? 29

Liability Questions • If a physician prescribed medicationrelated app erroneously advises the patient to take medications other than as prescribed—or otherwise malfunctions— and the patient suffers harm. Who is liable: the patient, the app makers, or the clinician? 30

Liability Questions Establishing an agreement around the use of any app with the patient may help to avoid misunderstandings that could lead to adverse outcomes. 31

• Acne applications which purported to treat acne by shining a light from a smartphone on the user’s face • $2 million settlement against a “brain training” app (Lumosity) which purported to reduce or delay cognitive impairments associated with age or health conditions 32

• $150, 000 fine Ultim. Eyes app that claimed to improve visual acuity (company doesn’t provide enough proof that the app works) • Application which claimed to calculate a mole’s risk of melanoma 33

34

Lawsuit Fitbit • Class action lawsuit - 2016 • Consumers in CA, CO and WI • Heart rate tracking is inaccurate http: //time. com/4344675/fitbit-lawsuit-heart-rate-accuracy/ 35

Lawsuit Fitbit • Class action lawsuit - 2016 • Consumers in CA, CO and WI • Sleep tracking technology • Suit claims overestimates sleep by 63 minutes https: //www. wareable. com/fitbit-sleep-tracking-lawsuit-2016 36

There’s an app for that! But is it any good?

Mobile Application Rating Scale (MARS) • • • Engagement – fun, entertaining to use Functionality – does it work, easy to use Aesthetics – overall visual appeal Information – Contains high quality information (e. g. text, feedback, measures, references) from a credible source. Subjective Quality – would you recommend, would you pay for it, how often would you use it Perceived Impact – impact for the user 38

39

40

IMS Health App. Script Score Overview 41

Professionals and consumers score for • • • Operability Privacy and Security Consumer appeal Functionality Usability Then give a grade of A, B or C. 42

Apps available at MCW Libraries 43

44

45

46

Questions? 47