Mobile Health App Scams

The U.S. Food and Drug Administration has released guidelines for mobile health apps, and soon will have enforcement power to eliminate scams such as this one.

Smartphone and tablet users should be wary of mobile health apps whether they are on iOS or Android. The potential marketplace is enormous globally.  Euro regulators will also be surveying offerings from vendors as well.

If you’re worried about melanoma, head to the doctor — not the app store. On Monday, the Federal Trade Commission announced it has cracked down on two companies that charged customers up to $4.99 for apps that claimed to help them detect early signs of melanoma.

You get the idea. According to the FTC, the app makers had no evidence to provide support for their apps’ claims that they could assist consumers detect melanoma, which is a form of skin cancer.

The Mole Detective app first appeared in 2012 and was marketed by a U.S. company while MelApp appeared in 2011 from a U.K. firm. The apps sold from $1.99 to $4.99 in the Apple and Google app stores.

A search of Apple’s app store shows both apps have now disappeared, and a search for “melanoma” turned up no results.

The scheme is so far-fetched that the best way to explain it is through these pictures from the FTC, which show how the apps — named MelApp and Mole Detective — claimed to use smartphone cameras to assess skin conditions:

FTC to regulate sales of mhealth apps

In an announcement Monday, the FTC states marketers of MelApp and Mole Detective acted deceptively in claiming the apps can detect melanoma symptoms based on photographs a consumer uploads to the app. Two of the four companies involved with the apps have agreed to stop making unsupported and unsubstantiated claims.

"Truth in advertising laws apply in the mobile marketplace," said Jessica Rich, director of the FTC's Bureau of Consumer Protection, in the announcement. "App developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps."

The settlement with New Consumer Solutions prohibits the vendor from claiming an app can detect or diagnose melanoma unless the claim is supported by "competent and reliable scientific evidence in the form of human clinical testing of the device." It prohibits the company from making misleading or unsubstantiated health claims about a product or service, and includes a $3,930 fine. The FTC is pursuing a litigated judgment against non-settling defendants Lasarow and his company.

In regard to MelApp, marketing began online in 2011 by Health Discovery, which sold the app for $1.99. The FTC settlement bars the company from the same stipulations cited for New Consumer Solutions. The settlement prohibits Health Discovery from making any other misleading or unsubstantiated claims about a device's health benefits or efficacy, and includes a fine of $17,963.

The FTC decisions were split votes, with a dissenting vote issued by Commissioner Maureen Ohlhausen in both cases.

For more information:
- read the FTC announcement
- read the commissioners' statement in favor of the decision
- read the dissenting commissioner statement

Potential buyers must be aware of scams in mobile health apps.  General health information apps have no regulatory oversite. However remote monitoring and wearable technology will require  certification by the FDA, FTC and other agencies as yet unknown.

The mhealth industry has to deal with  Blurred Lines during this relatively early period of development.

Before the Federal Trade Commission or Food and Drug Administration tackle another mobile health technology investigation, the two federal agencies--both of which are charged with protecting consumers--need to huddle up in a conference room, lock the door and not come out until they produce a clear map of what they're responsible for when it comes to oversight and regulating such tools.

Why? Because right now it's getting quite difficult to figure out who's keeping on eye on the shallow end of the mobile health technology pool and who's watching the deep end. And anyone who's had a pool or spent time at a public pool know that a lack of supervision at either end can lead to potential disaster.

the FTC describes itself as working "for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them." The FDA, for its part, describes its focus as being "responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."

That may be all well and good, but it really doesn't answer the big question: Is the FTC going to be the one and only lifeguard when it comes to the mHealth technology pool. Additionally, what role, if at all, will the FDA play as more mHealth cases come to light?

Mobile Health, Telemedicine and Walgreens

Walgreens app makes virtual doctor visits a reality

The service is immediately available to residents of California and Michigan and will be rolled out in other states in the next few years. Illinois residents should be able to use the app by the end of 2015.  Appointments cost $49, most of which goes to physicians. That fee is also not much more than a copay for an in-person doctor's visit through some insurance plans. “Some insurance companies cover telemedicine”, Leider said.

Walgreens is launching a virtual doctor visit feature on its mobile app, the company announced Monday. The nation's largest drugstore chain is teaming up with MDLive, a provider of virtual health services, to connect Walgreens customers with certified doctors via video chat on a smartphone, tablet or computer. 

"Consumers are demanding to do everything through mobile," Parker said. "Everything else they can do through mobile, and now they can do this too."

MDLive stands to gain 2 million people a day through Walgreens' mobile app and website. CEO Randy Parker said the company has 2,000 doctors available.

Last year Walgreens launched a Pharmacy Chat feature on its app to allow users to instant message with pharmacy staff. The company said it averages 9,000 chats a week.

"I think this will become a normal part of health care in three to five years," Leider said. "We have got some real forces that are going to make this very compelling."

He said a shortage of primary care physicians coupled with more people becoming insured through the Affordable Care Act means the market is growing for people who might find telemedicine useful.

Dr. Leider made the bold statement, “"I think this will become a normal part of health care in three to five years," Leider said. "We have got some real forces that are going to make this very compelling."

In October, Deerfield-based Walgreen announced a similar telehealth initiative partnership with health information website WebMD to encourage customers to increase exercise to earn discounts at Walgreens stores. The company said it now awards points on its Balance Rewards loyalty card for logging activities on the WebMD Healthy Target app.

The service is immediately available to residents of California and Michigan and will be rolled out in other states in the next few years. Illinois residents should be able to use the app by the end of 2015, said Dr. Harry Leider, chief medical officer  for Walgreens.  Appointments cost $49, most of which goes to physicians. That fee is also not much more than a copay for an in-person doctor's visit through some insurance plans. “Some insurance companies cover telemedicine”, Leider said.

"Consumers are demanding to do everything through mobile," Parker said. "Everything else they can do through mobile, and now they can do this too."

Chicago Tribune

ehirst@tribpub.com

HTE DIGEST Vol 1 No. 3

Telehealth puts powerful tools in the hands of providers

Honeywell HomeMed President John Bojanewski takes a look at the evolution of telehealth and its impact on the provider-patient relationship

Reimbursement issues have delayed adoption of telehealth, however

insurers and CMS are gradually accomodating it’s use.

mHealth still untapped resource for docs

For the most part, providers are still wary over the mHealth movement. And this caution just might be preventing them from big care improvement opportunities, say the findings of a new study.

Docs get mHealth help to handle tough conversations

In a sign that some companies are swinging back from consumer-directed healthcare and looking to help the providers, one firm is developing a web-based and mobile platform to assist doctors in talking to patients about changing difficult behavior patterns.

“The past and current model of direct to consumer marketing and sales leaves

the patient to making treatment decisions without collaboration with their provider”

Study: Docs need to promote mHealth apps

“As a corollary to consumers purchasing mHealth apps, doctors must provide leadership

collaboration with their patients.”  If patients are going to accept this a formula should be available for some insurance coverage or be certain the patient can and will be able to afford the application. A verbal recommendation should be reinforced with a written prescription, which has a stronger meaning.

Black Book names leading practice EHRs

“It's no easy feat to be the best, even in the healthcare IT space, but one EHR vendor has come out on top, earning the highest scores for client experience and customer satisfaction in the small practice category.” This news is germane because a large number of users are very dissatisfied with current EHRs.

More modern and contemporary EHRs are now in the market.  Replacement costs will be significant.

Why penalize the early EHR adopters?

The way John Berneike, MD, sees it, being an early adopter of electronic health records has put him in line for unintended punishment under Stage 2 meaningful use.  Many providers purchased new EHRs several years ago to meet requirements for interoperabilty and now are faced with additonal mandates, as well as another expensive change to diagnostic coding, expanding ICD-9 to ICD-10.

Health 2.0 India

The term Health 2.0 is an outgrowth of Web 2.0 as second generation internet technology and web sites developed in the last decaded of the 21st Century. It now is synonymou with the annual gathering of HIT professionals, including EMR,  HIE,  Mobile apps, Web Portals, and WiFi enabled embedded sensors

Health 2.0 has developed a global presence, beginning in the United States and expanding first to Europe, and Asia. Begiinning as a relatively small meeting it has grown exponentially.  The geographic diversity allows 'techies' in a wide variety of locations and cultures to meet and translate ideas as well as market to potential users. It serves well as a '"thought tank" for mobile health, consumer directed Many software development occurs at these meetings.

Health 2.0 India is the most recent iteration of the exposition.  It begins on February 7, 2014 in Bangalore, India.

2014 Topics will include :

• Designing an improved patient experience for a Billion people

• Trending – Startups, Funding and Accelerating Health 2.0

• Health 2.0 in the village

• Quantified self, wearable sensors and trackers

• Mobile health in real life

• Rise of big data and better decisions

• Pharma and better outcomes

• C-Level executives unplugged

• Unmentionables amplified – Sex, Sport & Rock n’ Roll

India has unique demographics and geographic criteria. It is heavily rural, with scattered villages, weak infrastructure and other limitations for networks. Rural communities often have no electricity. Telemedicine and televideo is highly desireable to spread the healthcare workforce.

One advantage is as infrastructure is built, cell phone, cable internet will be built with modern technology including fiberoptic backbone.

mHealth----More Necessary Regulations

Much of the big news in health IT this year came out of the Office of the National Coordinator for Health IT. ONC -- along with CMS -- is in charge of overseeing the widespread adoption of EHRs through the meaningful use program. After years in the works, the first phase of that program is wrapping up right now.

The past several years were almost frantic for HIT and ONC, with meaningful use standards, interoperability standards, incentive funding and a succession of creative and dynamic national coordinators, each with their own focus on what needed to be accomplished.

Unlike other Executive departments, Medicine has been fortunate to have a clear path, relatively clear goals, and minimal political divisiveness......all to the benefit of our patients.

mHealth has had an explosive growth in mobile applications for iOS and Android.  The hardware form factors are multiple with stiff competition and new hardware offerings almost monthly.

Growth and competition are plentiful and numerous manufacturers (Nokia, Windows, Google, Motorola,iPhone) in smartphone or pc tablet form.  In many cases EHR vendors have rapidly developed a mobile app portal.  The acceptance rate has been high for those who are tech savy.  Despite the potential vulnerability to a security breech and all that HIPAA stands by on the sidelines ready to pounce with a hefty penalty. The plain truth is that these applications and hardware offer so much to efficiency a way needs to be found quickly to certify HIPAA compliance for each application and device.

Not withstanding this urgent need there have been several attempts to regulate this market. FDA, FTC, FCC,  and HHS have all been mentioned. Suffice it to say that regulatory agencies are pressed to stay current with new hardware and devices.

Why, How and Which  Mobile Health applications need regulation?

In an article (blog post) in June 20012 I discussed  Five Reasons Why Digital Health Technologies Need FDA Oversight   Now the FDA is in the process of forming a mobile health division to study, certify and authenticate applications.  A new workgroup in HHS has been formed,

According to mobiHealthNews;

"The workgroup’s efforts will likely end up affecting the regulation of mobile health and health IT. According to HHS, FDASIA requires Sibelius, with the ONC and the FCC, to “develop a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including medical mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.”  The new workgroup’s input will feed into that report.

According to Brian Ahier,

"As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA regulates any given device as a medical device while FCC regulates the device as a communications device. 

Recognizing the potentially overlapping jurisdiction in digital health, in 2010 the agencies entered into a Memorandum of Understanding "to promote collaboration and ultimately to improve the efficiency of the regulatory processes applicable to broadband and wireless enabled medical devices."

Last month FCC announced its mobile body area network (MBAN) proposal, which would allocate electromagnetic spectrum for personal medical devices (see link below). The allocated spectrum would be used to form a personal wireless network, within which data from numerous body sensors could be aggregated and transmitted in real time."

Representative Marsha Blackburn (R-TN) and others introduced The Software Act.which will act to build a cohesive multi-agency over view of mHealth.

NIH Leader Calls for Evidence on mHealth

Only about 20 randomized clinical trials involving mHealth tools or services have been conducted in the United States since 2008 under the auspices of the National Institutes for Health. And more than half of them have failed to document clear evidence of improved outcomes.

 Francis Collins, MD, the NIH's director, delivered the message to attendess at the 2012 mHealth Summit in his closing keynote on Dec. 5. Collins pointed out that the lack of trial-based evidence is hindering acceptance of the technology by a healthcare industry that could really use these tools.

Dr. Collins also noted that controlled trials often are diffiicult to design in the real world by saying,

"The mHealth field is evolving so rapidly that oftentimes the technology used in trials is outdated by the time the trials are completed. For that reason, he said, the scientific and healthcare communities have to work together to fine-tune the process, producing viable results in a timely manner.

The alternative? Forge ahead with mHealth without evidence that mHealth is improving healthcare."

This viewpoint may be highly biased as to the cohort and demographics of such a study.  Presently there are thousands of mobile apps in development, most stimulated by public perception and enthusiasm from the HIT community. The feeding frenzy for profit is dynamic with the federal stimulus packages.

Many vendors in mHealth would argue differently. Hopefully some of them will comment here.

[See also: New bill would create FDA mHealth office.]

Steve Case cautions digital health entrepreneurs not to build “printer drivers” | mobihealthnews

mHealth during 2012-2013 did expand exponentially as predicted by many HIT experts...Steve Case and Esther Dyson give up their recommendations regarding mobile apps and the unique characteristics which require a comparison with the growth and acceptance of other services, such as AOL.

Citing his experience at AOL, Co-Founder Steve Case told attendees at the mHealth Summit this week that entrepreneurs in new markets typically will experience three phases as a newer field like digital health matures: hype, hope, and happiness.

Hype, of course, is one of the first phases when most everyone is excited about the potential, but “revolutions happen in an evolutionary” way, Case said, they don’t happen overnight. The hope phase is when expectations crash for one reason or another and only the most passionate and committed entrepreneurs decide to stick it out. Case said at that time the passionate ones even “double down”. The happiness phase is later when things are going well and the market is relatively established.
For AOL and the rise of the internet, Case said it took 20 years for it to become established and mainstream. Even by the end of first decade, Case said it appeared that the skeptics were right — only about 3 percent of the general population was online and for only about one hour each day on average. It took that much time to get the infrastructure in place, however, and during the second decade adoption ramped up as services flourished.  Case said that by his count digital health is already about one decade in.

Widely lauded angel investor Esther Dyson joined Case on-stage at the event to help put the digital health market’s progress in perspective. She said that the entrepreneurs in this market are not “healthcare transformers” but “creators” rooting at the edges of healthcare with something new. Mobile phones didn’t compete with landlines at first, Dyson reminded the audience. What they are creating will be called “health”, she said, not healthcare.
Dyson also noted that digital health entrepreneurs are fairly different from the early PC and dotcom entrepreneurs from previous decades.
“[In digital health] it’s not just enough to change behavior, but also did it change outcomes?” Dyson asked. One of the companies in her portfolio, Voxiva, has a smoking cessation tool that “doubles the rate of quitting,” she said. That’s good, “but that’s something like 10 percent instead of 5 percent. That’s pathetic. [Digital health] still has a long way to go.”

Steve Case cautions digital health entrepreneurs not to build “printer drivers” | mobihealthnews