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Rescooped by Giuseppe Fattori from Digital Disruption in Pharma
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AMA Adopts Principles to Promote Safe and Effective Mobile Health Applications

AMA Adopts Principles to Promote Safe and Effective Mobile Health Applications | #eHealthPromotion, #SaluteSocial | Scoop.it

The American Medical Association has signaled its support for mHealth with new policies designed to support physicians adopting mobile health apps and devices.

 

While approving an eight-part set of mHealth principles at its mid-year meeting this past week, the AMA also called for better regulation of apps – especially those which don’t fall under federal review – and told doctors to seek a legal opinion if an app’s security is questionable.

 

“While some mobile apps and devices are subject to FDA regulation, others are not, and do not undergo rigorous evaluation before deployment for general use, which raises quality and patient safety concerns,” the AMA’s Council on Medical Service said in a report adopted at last year’s interim meeting. “Without ensuring that there is strong and sufficient evidence that provides clinical validation to mHealth apps and associated devices, trackers and sensors, physicians will not fully integrate mHealth apps into their practices. More investment is needed in expanding the evidence base necessary to show the accuracy, effectiveness, safety and security of mHealth apps.”

 

As reported in AMA News, the organization approved a set of principles dictating that mHealth technology should:

 

  1. Support the establishment or continuation of a valid patient-physician relationship;
  2. Have a high-quality clinical evidence base to support its use and ensure mHealth app safety and effectiveness;
  3. Follow evidence-based practice guidelines, especially those developed and produced by national medical specialty societies and based on systematic reviews, to ensure patient safety, quality of care and positive health outcomes;
  4. Support care delivery that is patient-centered, promotes care coordination and facilitates team-based communication;
  5. Support data portability and interoperability to promote care coordination through medical home and accountable care models;
  6. Abide by state licensure laws and state medical practice laws and requirements in the state in which the patient receives services facilitated by the app;
  7. Require that physicians and other health professionals delivering services through the app be licensed in the state where the patient receives services or be providing these services as otherwise authorized by that state’s medical board; and
  8. Ensure that the delivery of any services via the app be consistent with state scope of practice laws.

Via Pharma Guy
Pharma Guy's curator insight, November 16, 2016 2:14 PM

Related articles: 

  • “AMA CEO Calls Out Medical Apps as ‘Digital Snake Oil’"; http://sco.lt/8zuIld
  • “AMA Survey Finds That Many Physicians Are Enthusiastic About Digital Health Tools, But Few Currently Use Them”; http://sco.lt/8b9r97
Rescooped by Giuseppe Fattori from Pharmaguy's Insights Into Drug Industry News
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The End of Pharma TV? Not Likely! But Consider a Partial Ban

The End of Pharma TV? Not Likely! But Consider a Partial Ban | #eHealthPromotion, #SaluteSocial | Scoop.it

In a recent 30 minute network “news” program, I counted 21 commercials/promos, half of which were for prescription drugs, most with computer-generated names that include Xs and Zs, aimed primarily at the AARP/Medicare generations, the largest consumers of these drugs (and the only ones who still consistently watch network evening news programs). Most popular magazines — yeah, there are still a diehard few who actually buy print media — contain multi-page ads for these drugs.

 

The ads, which mostly feature happy seniors leisurely riding in vintage autos or walking/biking/dining/boating/taking photos in bucolic, sun-dappled settings (except when playing lovey-dovey in adjacent bathtubs), with the injunction to “talk to your doctor to see if (fill in the name) is right for you,” have proliferated like amoeba since restrictions on drug ads were removed by the Food and Drug Administration in 1997 (the U.S. and New Zealand are the only two countries that now allow direct marketing of prescription drugs). Pharmaceutical company profits have soared as a result of the ad barrage.

 

In 2014, the companies spent $4.53 billion on ads for prescription drugs. But that pales in comparison to the $24 billion they spent in 2014 on campaigns aimed directly as physicians, many of whom get hundreds of thousands of dollars from the companies in “speaking fees,” meals, gifts, and other perks.

 

The American Medical Association, to its credit, has asked the federal government to ban these direct marketing ads. Citing “a growing concern” among physicians about the negative impact of these constant promotions directly to the pubic, it says, “A growing proliferation of ads is driving demand for expensive treatments despite the clinical effectiveness of less costly alternatives.”

 

Given that Big Pharma is, year-in year-out, the top spender on lobbying members of Congress, and that legal challenges would certainly follow any ban of the TV ads, the AMA request has about as much chance of passage as the proverbial snowball in Hades.


Via Pharma Guy
Giuseppe Fattori's insight:

I once said that banning DTC advertising is about as likely as Donald Trump being elected president. You know where that's going! 

 

What I propose is an experiment. Let's eliminate TV broadcast DTC advertising of brandname drugs altogether for one year, but keep print and Internet-based DTC advertising. That is, no broadcast DTC for ANY drug, new or old.

Drug companies could pocket the money saved or spend it on print and Web promotions or on disease awareness TV ads, which are not a target of DTC critics in Congress and elsewhere.

Pharma Guy's curator insight, March 1, 2016 2:58 PM

I once said that banning DTC advertising is about as likely as Donald Trump being elected president. You know where that's going! 

 

What I propose is an experiment. Let's eliminate TV broadcast DTC advertising of brandname drugs altogether for one year, but keep print and Internet-based DTC advertising. That is, no broadcast DTC for ANY drug, new or old.

Drug companies could pocket the money saved or spend it on print and Web promotions or on disease awareness TV ads, which are not a target of DTC critics in Congress and elsewhere.

eMedToday's curator insight, March 1, 2016 10:33 PM

I once said that banning DTC advertising is about as likely as Donald Trump being elected president. You know where that's going! 

 

What I propose is an experiment. Let's eliminate TV broadcast DTC advertising of brandname drugs altogether for one year, but keep print and Internet-based DTC advertising. That is, no broadcast DTC for ANY drug, new or old.

Drug companies could pocket the money saved or spend it on print and Web promotions or on disease awareness TV ads, which are not a target of DTC critics in Congress and elsewhere.