Experts advocate for modernization of FDA regulatory approach

The U.S. Food and Drug Administration (FDA) has been urged to “adopt significant fundamental changes to keep pace with medicine and technology” by Washington D.C. firm Epstein Becker Green and legal counsel from the mHealth Regulatory Coalition. 

 

The law firm, known for its work with mHealth companies, submitted the request as part of a white paper submitted to the Office of the National Coordinator (ONC) for Health Information Technology.  The 12-page paper comes in response to the ONC’s request for public comments as part of the development of health information technology regulatory framework in collaboration with the FDA and the Federal Communications Commission (FCC). 

 

According to HealthcareITNews, the paper, titled Enhancing Innovation in e-Health through a Systems Approach to Regulation: A Blueprint for FDA Modernization, is calling on the FDA to update its regulatory approach as a result of the changing medical technology landscape. 

 

As earlier reported on the Fountainhead Blog, the FDA has been involved in the regulation of mobile medical apps. Guidance for mHealth apps has been ongoing and many bodies are waiting for a cohesive decision to be made.  Healthcare information technology stakeholders are waiting for the ONC, FDA and FCC to come up with the regulatory framework that was mandated by FDASIA.

 

The whitepaper focuses on the need for these three agencies to work together: "Having multiple agencies overseeing a particular industry creates a substantial risk of throwing sand in the gears of innovation through duplicative and disjointed regulation. It can be very hard to serve two masters, let alone three," the paper stated. "In the case of e-health, the government didn’t set out to have multiple agencies regulating product development, but through the convergence of the technology, FDA, ONC and FCC can all now find themselves regulating the same products."

 

The paper goes on to outline areas where the FDA should look to modernize and tighten their regulations. One example comes in the use of collaboration, saying the governing body should allow more alliances between vendors, clinicians and scientist in new technology development. 

 

(image from biomet.com)

The authors of the paper believe that the FDA’s current regulatory system can address e-health after it has been modernized. Now the authors, along with the rest of the mHealth world, await the submission of the FDASIA’s findings, and more importantly, the final proposed strategy for presentation for Congress.

 
 

Med students use mobile as number one reference tool

A recent survey from physician reference app developer Epocrates has found that 66 percent of medical students look to the Internet or a mobile device as a reference guide. 

 

(image from medicalmmc.com)

The Future Physicians of America survey evaluated 1,026 current medical students and covered multiple topics, including their digital habits.  According to MobiHealthNews, the survey was conducted online and respondents included students from more than 200 medical schools across the United States.

 

With mHealth expanding, the findings of the study are not surprising. Of the 66 percent referred to above, 53 percent use mobile sources and 47 percent use the internet.  Additionally the study found that 54 percent of those surveyed used a tablet – up 31 percent from the previous year.  Not only are medical students using tablets, they are using them voluntarily as only 18 percent are required to do so.  Medical students use tablets to find clinical data, to view records and to communicate with colleagues. 

 

While these medical students would recommend health-related apps to future patients, social media is a no-no. Ninety-one percent of those surveyed believe it is unacceptable to friend a patient and 82 percent are against posting case photos. 

 

Within a few years, these medical students will join those doctors who are already using mobile technologies as part of their practice. Are you onboard with the future of medicine? 

 
 

Mobile app development: a significant business investment

With 19.4 percent of media time spent on apps, mobility has gained status as a business mainstay. 

 

(image by www.emarketer.com)

 

Forbes recently looked into mobility’s role in long-term strategy development, finding that it can make the difference between gaining and losing a customer’s business.  To ensure that your company is successful in capturing the greatest market share, the news organization has offered examples of mobile app developments that have made a splash in the industry:

 

  1. Why apps make sense:  Forbes references a study by Soulati Media that predicts 4.4 billion app users worldwide by the end of 2017. Apps are a long-term business investment – not a short-term fad. This technology can help increase brand awareness and can integrate into overall long-term goals. 
  2. Digital is the future:  Organizations like Starbucks are laying the groundwork for mobile transactions. More than 10 percent of the coffee giant’s payments are accepted through their app. Is this a business strategy your business uses?
  3. The mobile transition:  Apps are preferable to the mobile web.  Accessibility, coupled with mobile-only features, has enabled a better interface for users. 
  4. The hybrid approach: With the continuing battle between native, Web and hybrid apps, businesses are looking to make the best investment. Data from Gartner shows that 50 percent of apps will be developed using a hybrid platform by 2016 due to their flexibility, portability and effortlessness. 

 

Has your business made the mobile investment? If not, what is holding you back? 

 
 

mHealth phenomenon is here to stay

Many in the healthcare technology industry are questioning whether mHealth will be another fad. A new infographic from CDW Healthcare shows that this is no trend.

 

CDW Healthcare crafted the infographic below from a number of different sources, finding that doctors themselves are one of the biggest drivers of this technology.  Thirty-four percent of doctors are using apps to observe data from medical devices, compared with only 17 percent in 2012. 

 

Have you seen the mHealth trend in motion? What has your experience been like?