“That it will ever come into general use, notwithstanding its value, is extremely doubtful because its beneficial application requires much time and gives a good bit of trouble, both to the patient and the practitioner.”

“That it will ever come into general use, notwithstanding its value, is extremely doubtful because its beneficial application requires much time and gives a good bit of trouble, both to the patient and the practitioner.”

• GE’s Pocket Mobile Echocardiography (PME) device

• Fully half of U.S. adult cell phone owners (50%) now have apps on their phones.

• 17% have used their phone to look up health or medical information and 29% of cell owners ages 18-29 have done such searches.

Top 10 health searches from mobile devices in 2011

1. Chlamydia2. Bipolar disorder3. Depression4. Smoking/quit smoking5. Herpes6. Gout7. Scabies8. Multiple Sclerosis9. Pregnancy10. Vitamin A

• 9% have software applications or "apps" on their phones that help them track or manage their health. Some 15% of those ages 18-29 have such apps.

• By the summer of 2012, the number of iPhone apps for healthcare professionals will jump from almost 4,000 today to nearly 6,000 apps.

• Based on growth trends, by August 2012 there will be more than 13,000 iPhone health apps available for consumers.

Wait, wait, wait;let’s back up for just a second

• 83% of U.S. adults own a cell phone.• 35% of U.S. adults own a smartphone and

one-quarter of them use their phone as their main source of internet access.

• The highest level of mobile telephone use is among adolescents, younger adults, socioeconomically disadvantaged populations, less educated young adults, and people who rent or frequently change addresses. (Franklin, 2003; Faulkner, 2005; Koivusilta 2007)

• Further, a high level of mobile telephone use is associated with lower levels of self-rated health, higher BMI, and engaging in health-compromising behaviors. (Lajunen, 2007; Koivusilta, 2005)

mHealth describes a broad range of telecommunications and multimedia technologies within a wireless care delivery architecture.

The scale of interventions ranges from simple, direct-to-consumer applications to more complex systems that remotely coordinate and actively manage patient care.

Continuum of mHealth tools

Measurement• Sensor sampling in

real time• Integration with

health data

Diagnostic• POC Diagnostics• Portable imaging• Biomarker sensing• Clinical decision

making

Treatment• Chronic disease

management• Remote Clinical

trials• Disaster

support/care

Global• Service Access• Remote

treatment• Dissemination of

health information

• Disease surveillance

• Medication tracking and safety

• Prevention and wellness interventions

Top ten targets for mHealth• Alzheimer’s: 5 million Americans. Wireless sensors can track the vital signs of patients as well

as their location, activity, and balance.• Asthma: 20 million Americans. Wireless can track the respiratory rate and peak flow so

patients can use inhalers before an attack occurs.• Breast Cancer: 3 million Americans. Women can use a wireless ultrasound device at home

and send the scan to the doctor–won’t have to go in for a mammogram.• Chronic Obstructive Pulmonary Disorder (COPD): 10 million Americans. Wireless can

monitor FEV1, air quality and oximetry.• Depression: 19 million Americans. Wireless can monitor medication compliance, activity and

communication.• Diabetes: 21 million Americans. Wireless can monitor blood glucose and hemoglobin.• Heart Failure: 5 million Americans. Wireless can monitor cardiac pressures, fluids, weight and

blood pressure.• Hypertension: 74 million Americans. Wireless can continuously monitor blood pressure and

track medication compliance.• Obesity: 80 million Americans. Wireless scales can track weight and wireless sensors can

track calories in/out and activity levels.• Sleep disorders: 15 million Americans. Wireless sensors can monitor each of the phases of

sleep for quality of rest, detect apnea and track vital signs.

Cost efficiencies from mHealth address rapidly rising healthcare costs due largely to chronic disease

Analysts forecast strong growth for mHealth

iTunes Room for Healthcare• Reference Apps: Physicians sort through an overwhelming amount of information in

the course of diagnosing and treating patients. So having medical information available on demand, at any point throughout the day, is absolutely essential. Mobile access to this vital information must be intuitive, quick, and easy to interact with and view. Clinical reference apps on iOS deliver all this and more.

• Education Apps: This category of apps give both practicing physicians and medical students access to the educational content they need, even when they’re on the go.

• EMR & Patient Monitoring Apps: Electronic Health Records (EHR or EMR). Stimulus funding from the Federal Government for hospitals and private practice to move to electronic records is driving a lot of development and innovation in this space. Patient monitoring apps are changing the paradigm of how information is received by physicians.

• Imaging Apps: Allows physicians to connect to hospital PACS systems to view DICOM images on the iPhone and iPad – anytime – anywhere.

• Point of Care Apps: For physicians to use with their patients at the bedside.• Personal Care Apps: Wellness apps for consumers.

Physicians were not responsible for the improvement. – No additional meds– No significant changes in management

• The mechanism appears to be patient self-awareness, accountability

• An adherence mechanism is important

• Providing a monitor is not enough

mHealth is patient-focused, social, and consumer-initiated.

Privacy & Security

• AMA app includes this disclaimer:"When you purchase this application, you will be

responsible for protecting the privacy and security of the information that you enter, and for deciding who to disclose, and give access to, the information. The AMA assumes no responsibility, and shall have no liability, for protecting the privacy or security of the information entered in the application or shared with others either intentionally or unintentionally."

FDA Regulation8 Definition of Device SEC. 201. [321] For the purposes of this Act – (h) The term "device"

… means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--

• (1)recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

• (2)intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

• (3)intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

• “FDA may regulate certain mobile phones, accessories”, a mobile phone could become a regulated medical device if the manufacturer, through its words and deeds, conveys an intention that the phone be used in medical applications.

So, are they any good?

• To examine the content of existing iPhone apps for smoking cessation– Quality of apps– Popularity of apps– Relationships between these variables

Cessation programs should:

• Ask for tobacco use status• Advise every user to quit• Assess willingness to quit• Assist with a quit plan• Recommend approved meds• Practical counseling• Intra-treatment social support• Connect to a quitline• Enhance motivation• Arrange for follow-up

• Code for 20 measures of adherence to the US Public Health Service’s 2008 Clinical Practice Guidelines for Treating Tobacco Use and Dependence

• Two independent coders• From iTunes, obtain data on download

frequency and user rating of each app

• Currently available smoking cessation apps have low level of adherence

• The most popular and highly rated apps are not the most adherent

• Apps could be improved by addressing clinical practice guidelines

• Future research should evaluate revised and new apps– NCI Smoking Cessation App– HHS SmokefreeTXT

Design & Development

Consumer expectationsUI/UXGraphic design Platform / OSUsability testing

Workshop on mHealth Evidence• Collaboration between Robert Wood Johnson,

McKesson foundation, NSF and NIH• Randomized control trials are challenging in the

fast-paced world of technology. Need alternate methods

• Workshop to assess the design and analytic possibilities for developing evidence in mHealth

• August 16, 2011 at NIHhttp://obssr.od.nih.gov/scientific_areas/methodology/mhealth/mhealth-workshop.aspx

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If we keep practicing medicine as we know it today, healthcare will became an unbearable burden on all modern societies in a very near future. We are in a real race between healthcare innovation that can change this worrisome trend and the resistance to change inherent to our healthcare system.

Elias Zerhouni, MDDirector, National Institutes of HealthMay, 2002 – October, 2008

Contact me:

@medicfurby

Robert D. Furberg, PhD, MBA919.316.3726rfurberg@rti.org