FDA revises final guidance for mobile medical apps

FDA revises final guidance for mobile medical apps and the new final, final guidance is just one sentence SOURCE: MobiHealthNews, 4/1/2014, by Aditi Pai The FDA rescinded then re-released its (now final) final guidance for mobile medical apps (MMA) today and promised that this will be the final time the FDA will amend the document. The new, new guidance differs from the document released in September 2013 in two important ways. The first is that all founders and C-level executives of companies developing mobile medical apps are now required to attend medical school before marketing medical apps. The second change to the original final guidelines is that, in an effort to provide maximum clarity, the FDA has erased all of its other MMA guidelines. “The agency is sick and tired of being hauled in front of Congress to explain that sometimes software behaves like a medical device,” an FDA spokeswoman said in a statement. “Frankly, we just couldn’t take it anymore. The FDA has never regulated the practice of medicine — that’s between a patient and their provider. With these new, new MMA guidelines, the FDA can take a backseat, encourage doctors to use their free time to run health startups, and finally let innovation flourish.” The FDA suggests that founders and executives at mobile medical app companies take an accelerated program (just seven years!) at a local medical school or hand the company over to someone who is already a physician. When news of the final, final guidelines was leaked two weeks ago, there was an initial uproar from entrepreneurs in the digital health world, but now the health startup founders have either resigned themselves to their MCAT prep books or gone back to developing ecommerce apps.

Nielsen’s Connected Life Report: 15% of consumers who know about wearables own one

Fifteen percent of consumers who know about wearables own one.

SOURCE: MobiHealthNews, 3/24/2014, author: Aditi Pai

Fifteen percent of consumers who know the term “wearable” are also wearing one, according to Nielsen’s Connected Life Report, which surveyed 3,956 respondents last November. Those who were surveyed are either users of “connected life technologies” or interested in them.

Of those who owned a device, 61 percent owned fitness wristbands, which were distinct from people who owned smartwatches, 45 percent. And in a broader undefined “mobile health device” category, 17 percent of people owned a device.

“What motivates consumers to purchase wearable tech depends largely on the type of device and the benefits each offers for their everyday lives,” Nielsen’s researchers wrote in a summary of the report’s findings.

Thirty five percent of smartwatch owners said they bought a smartwatch because they had a “smartphone addiction” and 57 percent of fitness band owners said they bought the band because were concerned about and wanted to monitor their health.

Functionality and comfort were almost equally valued by smartwatch respondents — 81 percent prioritized functionality and 79 percent of consumers prioritized comfort. Wristworn fitness band owners rank accuracy of the device as most important at 70 percent and battery life at 64 percent.

Nielsen believes for the masses to adopt these devices, costs need to go down — 72 percent of respondents wanted wearables to cost less and 62 percent wanted wearables to take on different forms (beyond the wrist). Another 53 percent wanted wearables to look like jewelry.

Forty-eight percent of those surveyed were between the ages of 18 and 34 and 75 percent of those surveyed considered themselves early adopters of technology. The other option for this question was to consider yourself mainstream. Around 29 percent of respondents had an income of $100,000 or more, which Nielsen categorized as a disposable income.

Sleep Disorder Dx Market Rising Rapidly

Sleep Disorder Diagnostics Market Rising Rapidly. The market is drawing investors due to the tilt in preference from drugs to home care sleep tests that are more convenient and lack side effects.

SOURCE: By: Nathan Eddy | Date: 3/17/2014 | Publication: eWeek

The market for sleep disorder diagnostic devices earned revenue of $95.6 million in 2013 and estimates this to reach $125.8 million in 2017, according to a report from research firm Frost & Sullivan.

The diagnostic devices covered in the research included clinical polysymnogram (PSG) and ambulatory PSG systems. PSG is a type of sleep study, a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine.

The PSG monitors many body functions including brain (EEG), eye movements (EOG), muscle activity or skeletal muscle activation (EMG) and heart rhythm (ECG) during sleep.

"There is a growing demand for devices that offer integration and connectivity in sleep centers and home settings," Frost & Sullivan health care research analyst Akanksha Joshi said in a statement. "In this environment, cloud-based services could very likely change the dynamics of the market."

The report noted a large pool of undiagnosed patients and the growing population of the elderly in both Europe and North America point to a rapidly growing end-user market for sleep disorder diagnostics devices. -

In addition, the market is drawing investors due to the visible tilt in preference from drugs to home care sleep tests that are more convenient and lack side effects.

"Vendors that offer self-help devices have the potential to erode the share of sleep centers that offer sleep tests, as self-help technology can decrease the number of visits to physicians and overnight stays in clinics," Joshi continued. "Overall, a manufacturer that offers accurate data through real-time device connectivity involving the insurer and physicians as well as a precise predictive model for better patient outcomes will elicit greater interest in its product line."

Information technology is playing an increasingly important role in the transformation of the sleep disorder treatment market, the report said.

For instance, user-friendly disruptive technologies that are easy to operate and safe are finding considerable uptake among elderly patients considering their interest in alternatives to medications and traditional sleep disorder tests.

Another factor that could tip the balance in favor of home care devices is the limited availability of technicians, which leads to long waiting hours.

The lower rate of specialized physicians also reduces the total number of tests being conducted, thus reducing the number of sleep centers present.

Furthermore, the market is grappling with the issue of inadequate numbers of technically sound sales personnel, which lowers the number of units sold.

"Despite these considerable challenges, participants can shore up their sales by addressing the specific needs of the elderly," the report concluded. "Manufacturers are already collaborating with sleep centers, primary care physicians, and third-party companies that facilitate the renting of devices to satisfy market needs and build robust relations with customers."

For more information:  http://www.eweek.com/it-management/sleep-disorder-diagnostics-market-rising-rapidly.

Mobile Health Investment News: PatientTouch Secures $3M Strategic Investment

Telus’ $3M Strategic Investment to Bring PatientSafe to Canada

Full Article Below.

SOURCE: MobiHealth News, 3/12/2014, author: Jonah Comstock

PatientSafe Solutions, maker of mobile hospital workflow system PatientTouch, has secured a $3 million strategic investment and resale agreement from Telus Health, the healthcare arm of Canadian mobile operator Telus.

“This investment and exclusive reseller agreement is the latest validation of PatientSafe’s approach to supporting the future of healthcare on a global scale,” Joseph Condurso, president and chief executive officer of PatientSafe Solutions, said in a statement. “We appreciate Telus’ support and look forward to working with the company to bring the PatientTouch system to Canada. Together, we can provide healthcare organizations with smart point-of-care mobile tools that can drive better outcomes, safer care, lower costs, as well as patient and care team satisfaction across the healthcare continuum.”

The investment, which brings PatientSafe’s total funding to $66.4 million, will be used to help scale adoption of PatientTouch, the company’s self-proclaimed all-in-one healthcare offering for the iPod Touch. PatientTouch consists of an iPod Touch with a special rugged case equipped with a barcode scanner. Hospitals can use it in medication administration, specimen collection, infant care, care interventions, and care team communications.

Telus’ strategic investment follows a similar investment last fall from EDBI, the investment arm of Singapore’s Economic Development Board. EDBI’s $7 million investment facilitated PatientSafe’s expansion into Asian markets. Telus Health’s investment brings PatientSafe Solutions into the Canadian market, but it also gives Telus exclusive rights to resell the system in Canada. Telus Health’s OACIS Clinical Information system and EMR systems are already deeply interoperable with PatientTouch, according to the companies.

“The PatientTouch system has already demonstrated its potential in the United States, having been embraced by leading institutions,” Telus Ventures Vice-President Mathew George said in a statement. “We now look forward to bringing the technology north of the border to improve quality of care and positively impact patient outcomes.”

Previous investors in PatientSafe, formerly known as IntelliDot, include Merck GHI, Camden Partners, TPG Growth, and Psilos. Merck GHI led the company’s latest $20 million round in January.

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