FDA clears Sandoz and Pear’s Opioid Use Disorder app - PMLiVE #hcsmeufr#esante #digitalhealth
The app incorporates CBT to improve high relapse rates
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The app incorporates CBT to improve high relapse rates
A l’occasion de la JMH, le laboratoire Bayer lance une série d’applications digitales pour faciliter le quotidien des hémophiles.
Bayer vient de lancer 3 applications pour une approche globale à destination des hémophiles..une pour l'entretien physique, l'autre comme carnet de suivi et la troisième pour les professionnels. #esante #hcsmeufr #MBAMCI
Welcome to the October 31, 2017, issue of Pharma Industry News Update (aka PinUp).
Some experts are 'heartbroken' that the pharmaceutical industry has not done more in the digital health arena and they blame it on belief in "myths" about FDA regulations. Good luck busting those myths! Another myth is that education programs promulgating the old "just say no to drugs" campaign are going to help end the current opioid epidemic. The last myth that deserves mentioning is that the drug industry is not culpable.
**********ARTICLES***********
* Five Regulatory Myths About FDA Regulation of Pharma in the Digital Health Arena
* Trump Has Not Grasped What’s Needed to Combat Opioid Crisis
* Dancing with Fentanyl: Insys Sales Reps Caught Rapping to Boost Sales
Access this issue here.
About Pharma Industry News Update
The Pharma Industry News Update (aka PinUp) is published every Tuesday and Friday as part of the Pharma Marketing News subscription service. It features curated pharma industry news and views of topical interest from a variety of sources. If you'd like to receive this newsletter, subscribe here.
About the Author
John (PharmaGuy) Mack is a constructive critic of the pharmaceutical industry. You can follow him on Twitter as @pharmaguy
NYC-based pharma company Pfizer currently has 15 apps in the US iOS app store, ranging from a chapstick companion app to an app for people with kidney cancer. At the HIMSS Connected Health Summit in National Harbor, Maryland, Pfizer executives talked about two of the company's apps and their broader strategy for developing mobile health interventions.
"We recognize that the data shows patients expect meaningful digital solutions from us, and it is our obligation to deliver that," Judy Sewards, vice president of data and digital innovations, said. "When we think about it at Pfizer, we’re not thinking about what's the next shiny thing, or what's the next widget or what everyone else is doing, but looking through the lens of our patients as people."
For instance, Pfizer's app for smoking cessation, called Quitter's Circle, was developed in partnership with the American Lung Association. Dennis Hancock, Pfizer VP of global commercial solutions, said all the features of that app were driven by insights into the quitting process.
"It would be really easy to talk about buzzwords -- telemedicine, crowdfunding," he said. "While they’re important features to the app, they had to be driven by insights into what the smoker would find useful. I don’t think chasing features is a really good idea in the mHealth space. Let’s start with insights to know what people want and overcome those barriers using the best tools available."
Further Reading:
The future of schizophrenia is looking more and more digital as tech is being used to increase physical activity, deliver therapy & social support, help monitor
eHealth technologies have potential for engaging patients in their own care but must be closely aligned with a patient’s experiences and engagement needs.
Patient experience must be considered when developing eHealth tools to help boost engagement. Without considering the patient's journey, efforts will fall flat.
Digital smoking cessation company 2Morrow has partnered with GlaxoSmithKline, makers of Nicoderm patches, to offer the company’s Nicoderm CQ Patch to smokers who complete 2morrow’s cessation program.
Le week-end du 18 mars, la société pharmaceutique Pfizer accueille dans ses bureaux 100 profils créatifs pour le tout premier mHealth Hackathon officiel en Belgique.
If 2015 healthcare investment levels are any indication, investors the world over are focusing on patient experience above all other digital health investment subsectors.
A new study released by mobile engagement provider Mobiquityexposes the “gap between patients’ demand for taking control of their own health and the accessibility or availability of digital and mobile tools when it comes to the management of chronic health conditions.”
The study revealed that one third of patients with chronic diseases don’t currently use mobile apps to manage their conditions, but would like to start.
In fact, the report summary notes, one in four respondents feel that “wearable devices are the way of the future.”
Interestingly, almost 50 percent of patients believe they should bring information/digital tools to their doctor – rather than the other way around – reinforcing their desire to be actively involved in managing their health rather than trust their doctors to exclusively manage it.
When asked about the most challenging aspects of managing their conditions, 26 percent of respondents agree that finding direct means of communicating with health professionals presents the biggest hurdle. Other top challenges include:
“It’s clear the potential for digital solutions is vast: 40 percent of respondents feel mobile tools play an important role in overall healthcare,” the report summary reads.
For more about what patients want in mHealth apps, read "Patient Activists Demand Higher Quality Mobile Apps"; http://bit.ly/pmn130701pdf
It’s hard to find a pharma or medical device company these days that doesn’t have at least one mobile app in development. And now that, as of February 2015, the U.S. Food and Drug Administration (FDA) has issued guidance on which apps need to be regulated and which ones don’t, it will be interesting to see if this almost exponential development trend continues.
Federal guidance alone doesn’t guarantee an app’s success, and there is still plenty of playing field for developers in the health and wellness space for apps that do not require 510(k) submission. Therefore, developers and marketers alike must keep in mind these three key drivers of mobile health app adoption.
Awareness
In a 2014 poll by QuantiaMD, only 37% of physicians surveyed said that they had recommended a mobile app to their patients. In another QuantiaMD poll, 42% of physicians said they would notrecommend a mobile health app to patients because there was no regulatory oversight (though the new FDA guidance should help with this). In addition, another 37% percent had no idea what mobile health apps are out there.
In spite of physicians being split on the utility of apps, consumers are downloading them at a rapid pace. In fact, it is estimated that within the next three years half of all smartphone and tablet users will have at least one mobile health or wellness app, like Lose It!, RunKeeper, or Glucose Buddy. But, downloading doesn’t necessarily mean they are using them! There is enormous opportunity for healthcare marketers to more effectively demonstrate the myriad of app benefits to patients and physicians alike.
Experts say that the bulk of the apps recommended by physicians are related to diet and fitness, and that few physicians are “prescribing” apps with the expectation of receiving follow-up data. See here: http://sco.lt/5igoc5
Pharmaguy interviews Ralf-Gordon Jahns, Managing Director, research2guidance, who talks about his company's Pharma App Benchmarking 2014 report and what changes pharmaceutical companies must make in order to deliver more useful mHealth apps for healthcare professionals and patients and thereby become successful in the mHealth market.
Questions/Topics of Discussion
"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").
Note: There is no "2." in the algorithm, but I assume it's the last paragraph. In any case, the examples cited by the FDA may better illustrate FDA's thinking. Three out of 4 of these examples involve mobile apps:
Illustrative Example 1: A mobile application plays music to “soothe and relax” an individual and to “manage stress.”
These claims relate only to relaxation or stress management, not to any disease or medical condition, and thus are general wellness claims. In addition, the technology to play music does not present inherent risks to a user’s safety. Therefore, this product meets both criteria for a low risk general wellness product.
CDRH’s general wellness policy does not extend to devices that present inherent risks to a user’s safety.
Whether a device is low risk for purposes of this guidance is determined by whether or not the product:
is invasive;
involves an intervention or technology that may pose a risk to a user’s safety if device
controls are not applied, such as risks from lasers, radiation exposure, or implants;
raises novel questions of usability; or
raises questions of biocompatibility.
If the answer to any of these questions is yes, the device is not a low risk general wellness product and is not covered by this guidance.
Some see a future battle on what is & isn't low-risk. "If it's up to companies everything will be low-risk," said Moira Gunn (@biotechnation) on Twitter.
FDA clarifies what apps don't require review: Stress management, activity and food tracking, as examples.
more than one-third of respondents who are online said they were "very" or "extremely" interested in using smartphones or tablets to ask their doctors questions, make appointments or get medical test results.