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Will FDA Finally Make the Call on Mobile Medical Apps?

FDA's long-delayed release of the final mobile medical apps guidance may finally be within reach.

 

 

cell phone

 

When it comes to apps and mobile phones, speed is everything. Unfortunately, FDA can’t keep up. The sector’s fast pace of innovation and product development stand in stark contrast to the snail’s pace of progress on final guidance for the regulation of mobile medical apps (MMA). But with innovation at stake, patient safety at risk, the FDASIA Workgroup’s recommendations in, and the deadline for final MMA guidance looming, it’s time FDA provided a clear pathway and picked up the pace. 

Regulation of mobile medical apps will be a topic of discussion at MD&M Minneapolis

Released back in July 2011, FDA’s MMA draft guidance represented significant progress toward outlining a risk-based regulatory framework for these diverse and innovative new technologies. More than two years later, the flourishing mobile health (mHealth) landscape has altered even more dramatically as legions of developers line up to cash in on the booming health and wellness trend.

And yet, the problems, questions, and concerns remain unchanged. To patients’, developers’, and the industry’s detriment, the release of a definitive guidance on the regulation of mobile medical apps has been delayed by a blend of bureaucracy, conflicting political agendas, and—to a lesser extent—issue complexity.

“Somehow, this instructive document, intended to lift the fog of ambiguity, created quite a controversy in Washington policy circles,” Robert Jarrin, Qualcomm’s senior director of government affairs, and FDASIA Workgroup member wrote in a recent post to the company’s blog. “Inexplicably, a number of groups vehemently opposed the issuance of the MMA guidance.  They seemed to want to stifle FDA’s ability to issue any guidance while they worked to limit the way FDA regulates medical devices, in particular health IT, and not just mobile medical apps.”

Bradley Merrill Thompson, partner at Epstein Becker & Green, cochair of the FDASIA Workgroup’s regulation subgroup, and upcoming speaker on the subject of medical app regulation at MD&M Minneapolis, echoes this frustration. “[These groups] seem to want to freeze all forward progress at the agency until they’ve had time to get Congress to pass legislation that would presumably alter the landscape. I think that’s very shortsighted.”

Shortsighted, indeed. In the absence of definitive guidance, consistent enforcement, and a clear, risk-based regulatory framework for medical apps, a virtual free-for-all has occurred in the mHealth space. In particular, a lack of clarity around what, exactly, constitutes a medical device has been the source of much confusion as well as a loophole for many companies in the relatively nascent medical mobile app market. The definition of a medical device predates the emergence of app technology, after all, and its ambiguous nature leaves a lot of room for interpretation.

This ambiguity is particularly problematic considering that many app developers jumping on the medical, health, and wellness app bandwagon are outsiders unfamiliar with the regulated industry. Consequently, many developers either grapple with whether or not their technologies are subject to FDA review and what that entails or neither consider nor care about FDA regulation and compliance.

The result is an unregulated market abounding with apps that make unsubstantiated claims and mislead or potentially endanger consumers. “There are dozens—if not hundreds—of mobile apps that are on the market now that should have gone through the FDA clearance process,” Thompson states. “As to whether or not they’re dangerous or not, no one knows, right? The point of FDA review is to validate and make sure that products aren’t dangerous.”

Among the most notable apps to flaunt its seemingly medical device functionality is the uChek. Designed to convert a cell phone into a personal medical lab, the uChek caused a splash this past spring after a much-publicized TED talk explained how the app, in essence, performs urinalysis. Although most apps seem to be flying under FDA’s radar, the agency found it hard to ignore the high-profile app, and subsequently sent the company an “it has come to our attention” letter. The company later launched an unsuccessful crowdfunding effort on indiegogo to help pay for the 510(k) submission and other regulatory costs.

And while questionable apps are inundating the market, the introduction of truly innovative and potentially disruptive apps is somewhat stalled as savvy developers understandably proceed with caution. Thompson notes that companies whose apps fall into a gray area are hesitant to go to market because they don’t want to invest unnecessarily in compliance if they may not have to under the new guidance.

Furthermore, companies that are relatively certain that their apps will be subject to FDA review have pressed pause on development as they await clear guidelines that will tame the current Wild West app marketplace. “Even if a company understands it will be regulated, it doesn’t want to enter the space so long as FDA is not actively enforcing the rules against those entering without observing FDA standards,” Thompson says. “If FDA’s letting everyone go through, someone else could not pursue that costly activity and come to market with a 99-cent app and undercut [the legitimate company].”

The final guidance needs to clearly define when an app is a medical device and, thus, should be regulated; differentiate between a medical device app and wellness app; and avoid overregulation of low-risk apps. But to impose order among chaos and unfreeze the innovation pipeline, FDA needs to heed the advice of the FDASIA Workgroup and expedite final guidance. And fast. As of mid-September, the guidance has not been released; however, the September 30 deadline still lies ahead as a glimmer of hope. To reach that goal, though, FDA needs to act in the best interest of the public it serves and cut through the red tape in Washington. If only there were an app for that.  

 —Shana Leonard, executive editor, MD+DI
shana.leonard@ubm.com

It's

برامج تحميل ، ان البرامج

برامج تحميل ، ان البرامج اليوم هى المحرك الأساسى للكمبيوتر حيث ان لكل شىء محرك ، لتصميم صورة رائعة تحتاج الى تحميل برنامج تعديل الصور مثل برنامج فوتوشوب الشهير التابع لأدوبي ، كذلك ان اردت مشاهدة فيديو رائع ، يمكنك ذلك من خلال تحميل برنامج يوتيوب لمشاهدة جميع الفيديوهات والقنوات الاخبارية والاحداث العالمية من خلالة ، وان كنت من محبى سماع الصوتيات والنغمات يمكنك ذلك من خلال تحميل برامج الكمبيوتر . تنزيل بعض برامج الصوت مثل الريال بلاير او برنامج وين امب او الميديا بلاير وغيرها من برامج الصوت المشهورة والمميزة ، لذلك سوف نرى ان جميع برامج الكمبيوتر هى محركات اساسية للوصول لهدف محدد وواضح ، وان كل شىء يحتاج الى برنامج للتعامل معه بشكل كامل وبامكانيات تجعلك تتحكم فيه بشكل شبه كلي ، لذلك ينصح جميع المستخدمين بتحميل البرامج التى تحتاجها بشكل يومى ، كما ان خبراء البرامج والكمبيوتر ينصحون دائما باعتبار الكمبيوتر هو ناقتك التى تحملك فى عالم الانترنت ، وينصحونك بعدم تحميل البرامج التى لا تحتاج لها ، وان لا تنزل البرامج الا التى تحتاجها وتستخدمها بشكل دائم ، وان هذا هو أفضل إستخدام للكمبيوتر للحفاظ عليه والاستمرار بشكل جيد ودائم . تحميل متصفحات الأنترنت : يوجد العديد من المتصفحات الجيدة التي يمكنك استخدامها للتصفح فى المواقع ، ولكن سوف ننصحك بعدة برامج مميزات ومتصفحات رائعة اثبتت بالتجارب انها الأفضل على الاطلاق ، اهم هذه المتصفحات ، متصفح جوجل كروم ، متصفح فايرفوكس ، متصفح اوبرا . تطبيقات أندرويد : فى عالم الاندرويد سوف تجد ان برامج الاندرويد اصبحت هامة جدا وان تحميل تطبيقات الاندرويد وبرامج الاندرويد ، وخصوصا العاب الاندرويد التى أصبحت شبه واقعا مثل لعبة بوكيمون جو الشهيرة والتى ظهرت مؤخرا . اصبحت تحميل العاب من أكثر الاشياء بحثا وتحميلا فى هذا الوقت ، نظرا لسهولة اللعب ونتيجة ان العاب الاندرويد لا تحتاج الى جهاز كمبيوتر ، ولا تحتاج سوف الهاتف الذكي الذى تستخدمة بشكل دائم مما جعل اللعب اكثر متعة وسهولة ويمكنك ان تلعب هذه الالعاب فى السيارة او اثناء السفر او على الطائرة او فى اى وقت . برامج اندرويد : أنصحك باستخدام العديد من برامج الاندرويد ، ولكن يوجد عدة برامج انصحك باستخدامها ، اهم هذه البرامج برنامج واتساب اب ، برنامج لاين ، وتنزيل جميع تطبيقات الشات ، مثل تحميل فيس بوك ، تنزيل تويتر ، وغيرها من البرامج الهامة التى تستخدم فى التواصل الاجتماعى ، تحميل برنامج يوتيوب وتنزيل فيس بوك لايت ايضا فهو نسخة خفيفة لاستخدامه الفيس بشكل سريع وسهل ، تحميل برنامج ايمو وتنزيل برنامج تيليجرام ايضا فهو برنامج سريع مثل الواتس اب ،هذه البرامج الأكثر تحميلا فى تطبيقات الاندرويد والأيفون . الخلاصة : يوجد العديد من البرامج الهامة والتى نرغب فى استخدامها ، ولكن اهم هذه البرامج التى ننصحك باستخدامها هى برنامج وينرار وهو برنامج مشهور فى فك وضغط الملفات لسهولة ارسالها واستلامها على الانترنت ، برنامج ياهو ماسنجر فهو أول ماسنجر ظهر فى عالم الاتصال على الانترنت . كما ننصحك حجب المواقع الاباحيةايضا ، فهو برنامج هام جدا وعملي . يمكنك ايضا تحميل برنامج شير ات فهو من افضل البرامج الجديدة ايضا وننصح بتحميلة . وهذه تعتبر خلاصة لأفضل برامج تحميل كمبيوتر ويمكنك تحميل جميع هذه البرامج من الانترنت من خلال برنامج انترنت داونلود مانجر 2017الجديد واخر نسخة .

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mHealth IS Medical Device

Wow, is the rest of the "Health Software as a Product" going to be upset with me. Software that is connected with a medical device is regulated by authorities in every country. In fact, for years the FDA and most regulatory agencies have known that software in medical devices bears out sized hazards. So the regs address that.

Yes, it is burdensome, delaying and worse yet, demands a knowledge of medical product development. Do you really want to get sued because you recommended a dose of three gallons rather than three drops, or because a doctor told Billy Bob the image showed a tumor when the picture was of Billy Joe? But if it is a level playing field where everyone creates regulated, safe and effective mobile apps, get to the bad part.

The FDA has to regulate -- this ain't "Angry Birds". Yeah including 510(k) and PMA.

Device vs. wellness app

@Tom: Thanks for your feedback There's no doubt that FDA has and will continue to regulate apps that communicate with or act as an accessory to medical devices. The confusion and ambiguity seem to be more around apps that may fall into the health and wellness space and are not outright diagnosing or working directly with a medical device. For example, an app may specifically cater to a diabetic and track calories and other data in order to make recommendations for people with this particular disease or that prompts users to speak with doctors about the data revealed through the app. These types of apps are likely relatively low risk, but are influencing decision making around disease management in a way. So the lines are a bit more blurred.