mHealth Apps: Overwhelming Choice, Limited Proven Efficacy, Security Issues

According a new study just released by the IMS Institute for Healthcare Informatics, the number of mobile health applications (mHealth apps) available to consumers now surpasses 165,000. The study, Patient Adoption of mHealth: Use, Evidence and Remaining Barriers to Mainstream Acceptance, analyzed 26,864 apps available in the U.S. Apple iTunes and Android app stores -- a representative sample of the most widely used mHealth apps by consumers.

The problem is this: too many apps, too little efficacy in terms of health outcomes.

"The fast-paced growth of the healthcare app market has outpaced the ability to develop oversight and guidance for accuracy of clinical content contained in mHealth apps," concludes the report. "The sheer volume of choices in the consumer mHealth apps available in the absence of a mechanism for certifying or ranking apps leaves providers and consumers on their own to navigate app selection. This environment leads to provider reluctance in prescribing mHealth apps given the unknowns about accuracy, efficacy as well as security."

What's the solution?

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A Rare Rx Drug Branded Mobile App for Patients. Is It Just a Drug.com Site on Your Phone?

It's rare for a pharmaceutical company to develop a mobile app that includes brand name drug information. So, when I learned that Boehringer recently released a GILOTRIF branded iPhone/iPad app for people who may have NSCLC (non-small cell lung cancer), I immediately downloaded it.

Although I luckily do not have NSCLC and have not been prescribed GILOTRIF, I was able to open up the app and use it (see the opening screen on the left). That's why I say this app may be for patients prescribed the drug and who need support. But it could also be targeted to newly-diagnosed patients who may wish to learn more about GILOTRIF (i.e., it's a DTC ad just like a drug.com website).

The official name of the app is "My Treatment Guide" and you can find it on the iTunes app store here.

Boehringer has taken pains NOT to mention the indication for GILOTRIF in the iTunes description. Perhaps they read my blog post about Pfizer's LIPITOR app, which mentioned its indication but did not provide the necessary fair balance (i.e., major side effects) as required by FDA (read "Pfizer's Short-lived LIPITOR Branded Mobile App").

I say "necessary" because, IMHO, iTunes pages that mention brand name drugs qualify as prescription drug DTC ads that must comply with FDA regulations regarding fair balance (ie, it must include Important Safety Information or ISI).

So, kudos to Boehringer for that. I have a few more interesting observations about this app that you may be interested in reading.

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FDA Develops a Mobile App for Reporting Drug Shortages. But Wouldn't an App for Adverse Events Better Fit the Agency's Mission?

FDA/CDER launched its first and only mobile app on iTunes: DrugShortages (see logo on left).

The iTunes blurb suggests the public would find this information important:

"Access to drug shortage information is now easier and faster. FDA has developed an app that allows users to quickly identify current drug shortages, resolved shortages, and discontinuations of drug products. This app was developed to accelerate public access to important – and sometimes critical -- information about drug shortages. The application uses a searchable database to provide real-time information to key stakeholders, including health care practitioners and pharmacists."

I'm not sure how useful this app is for the public versus HCPs who definitely would like easy access to such information. According to the blurb, the app "helps health care practitioners make quick decisions about patient treatment."

More importantly, the app "provides information on how to report a shortage or supply issue, and links to other resources from FDA". Of course, the general public would not find this feature of the app very useful.

But an app that would be VERY useful for HCPs and patients is an app that provides easy access to adverse event data and that allows users to report adverse events. This, I believe, would better fulfill FDA's mission: to "protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices..."

What would such an app look like? I used the DrugShortages screen to create what I call "DrugAE," a concept for a mobile app that I hope the will FDA launch on iTunes soon. Here's my concept:

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Millennials Trust Pharma Social Media, Mobile Apps & Advertising a Hell of a Lot More Than Their Geezer Parents!

According to findings released today from the Fifth Annual Makovsky/Kelton “Pulse of Online Health” Survey, the percentage of Americans who trust pharma-sponsored social media "a lot" or "completely" increased from 17% in 2014 to 21% in 2015.

The same survey also revealed another trend: In 2010, 88% of Americans were willing to visit a pharma-sponsored Web site (e.g., a drug.com site), whereas in 2015 that percentage decreased to 80%.

Fielded in January 2015 to 1,015 nationally representative Americans ages 18 and older by Kelton, the Makovsky Health survey investigated consumers’ behavior and preferences for engaging with online healthcare information. The margin of error is +/- 3.1 percentage points at the 95 percent confidence level.

Meanwhile, a Prevention Magazine 2011 survey found that 49 percent of respondents who went online for prescription drug information reported seeking this information on a specific brand's Web site. As a consequence of this influence of the Internet, FDA is currently studying how consumers interact with drug.com websites (read this Pharma Marketing News article: Are Drug.com Websites "Fair and Balanced?").

Before commenting on the above results, let me summarize a few other “Pulse of Online Health” Survey results -- especially those related to mobile and wearable devices -- that may be of interest to you.

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FDA Says It Will Not Regulate Low-Risk Mobile Health Apps as Medical Devices

"CDRH [FDA's Center for Devices and Radiological Health] does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act," says a new guidance posted today on the FDA website ("General Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff").

Recall FDA's "Mobile medical apps Proposed Scope for Oversight" pyramid:

There are three parts of the pyramid:

1. The top of the pyramid includes mobile medical apps that are traditional medical devices or a part or an extension of a traditional medical device. Clearly within the scope of being regulated as medical devices. 
2. The middle section includes patient self- management apps and simple tracking or trending apps not intended for treating/adjusting medication. This is the area, as defined by CDRH, for enforcement discretion 
3. The bottom section are devices that are not deemed “mobile medical apps” and, as such, have no regulatory requirements.

The guidance released today is an attempt to define the boundary between parts 2 and 3 of the pyramid and to clarify what FDA meant in a 2012 guidance when it said this:

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Back to the Future of Mobile Health Apps with Professor SYRUM's Nephew

There is no more cherished and insulting image of a scientist/researcher than the "mad scientist" persona often depicted in cartoons.

A case in point is "Professor SYRUM" from Boehringer's EU-only Facebook game of the same name (see "Happy Holidays from Professor Syrum"). That's him on the near left.

Recently, I became acquainted with an unnamed scientist (physician? pharmacist?) in an animated piece produced by IMS Health to promote its new mobile health app review program (see "Is IMS Health's Mobile Health App 'Certification' Program Doomed to #FAIL?"). That's him on the far left of the image shown above. Let's call him "Doctor IMS."

Do you see the similarities between Professor SYRUM and Doctor IMS? Read on to learn my theory about how they are related.

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Is IMS Health's Mobile Health App "Certification" Program Doomed to #FAIL?

"Welcome to the wild, wild, west of mobile health apps," says the voice over of an IMS Health animated Youtube video (embedded at the end of this post) that promotes two new mobile health app services:

AppScript - "a secure, cloud-hosted mobile health prescribing solution that helps providers create custom app formularies to prescribe, reconcile and track mobile medical apps"; and 

AppNucleus - "the industry’s most secure app development and hosting platform that offers a flexible, cloud-based publishing platform and pre-built secure messaging, personal health record/wallet and survey tools."

Recall (here) that the IMS Institute for Healthcare Informatics published a report that included an analysis of about 10,000 apps among the 40,000+ healthcare apps available for download from the U.S. Apple iTunes app store and an assessment of the potential value they provide throughout a patient's journey. The assessment found that "healthcare apps available today have both limited and simple functionality... [and] do little more than provide information."

Obviously, there is a lot of room for the improvement of mobile health apps. I've written about this many times as it relates to the pharmaceutical industry (see, for example, Reigning in the "Wild West" of Mobile Health Apps and A Formula for Patient-Centric mHealth Apps).

Let's just focus on AppScript, which promises to "classify and evaluate more than 40,000 mobile healthcare apps currently available for download on iOS and Android platforms." I have some reservations about how successful this "Software-as-a-Service"/certification program will be.

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