One Drop for iPhone & Apple Watch is a dashboard & community for managing diabetes

The iPhone has become a mature platform for health and fitness software in recent years, especially since iOS 8 introduced HealthKit and the dedicated Health app followed by ResearchKit and a new set of medical apps. Today a new app called One Drop is launching with an ambitious goal: to help people with diabetes live a happier and healthier life. Read more

Apple needn’t fear over-regulation of Apple Watch health & fitness functionality, says FDA

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While health tech has to be approved by the Food and Drug Administration, the agency will be taking “an almost hands-off approach” to fitness-oriented wearables like the Apple Watch, says policy advisor Bakul Patel in an interview in Bloomberg.

“We are taking a very light touch, an almost hands-off approach,” Patel, the FDA’s associate director for digital health, said in an interview. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”

Patel said the FDA would be drawing a distinction between products whose health claims focused on fitness rather than diagnosis …  Read more

ResearchKit may go beyond individual studies, open up era of ‘open-source’ medical research

researchkit-future

We’ve already seen the potential of Apple’s ResearchKit platform to sign up large numbers of participants to medical studies in an incredibly short time, but a reported conversation between the founder of an open science non-profit and an Apple VP suggests that the potential goes far beyond this.

Fusion, in an extensive profile, reports that Apple may be intending to collect anonymised health data in a central database accessible to medical researchers around the world, enabling each to benefit from that shared data to forward their own studies. The vision was initially put forward at a conference back in September, long before ResearchKit was announced, by Stephen Friend, the founder of Seattle-based Sage Bionetworks, a nonprofit that champions open science and data sharing.

“Imagine ten trials, several thousand patients. Here you have genetic information, and you have what drugs they took, how they did. Put that up in the cloud, and you have a place where people can go and query it, [where] they can make discoveries.” In this scenario, Friend said, patients would be able to control who could access their information, and for which purposes. But their health data would be effectively open-sourced.

Apple reportedly took an immediate interest in the idea …  Read more

Apple makes key biomedical & fashion industry additions ahead of Watch launch

Apple Watch at Colette

Apple Watch at Colette

Apple has picked up a few new hires and advisors to assist its growing Watch team ahead of the Apple Watch launch currently on track for March. Among them, Apple has recently hired another executive from the fashion industry, this time from Louis Vuitton, in addition to two new hires from the medical industry. Read more

Apple unsurprisingly working with more healthcare providers ahead of iOS 8’s Health launch

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Reuters noted today that Apple is working with healthcare professionals at hospitals across the country, including Mount Sinai and John Hopkins, in preparation for the rollout of the HealthKit system in iOS 8. The goal is to ensure that medical personnel are ready to read data from the system when it ships later this year.

This move is hardly surprising, as Apple intends HealthKit to serve as a collection place for all of a user’s health-related data, which can be valuable—even lifesaving—during a medical emergency. In fact, the Mayo Clinic demoed the first HealthKit-enabled application earlier this year during WWDC:

Read more

RunKeeper, Withings, Strava, & iHealth plan HealthKit integration, excited for medical industry tie-in

Healthkit-WWDC-01

Whenever Apple introduces a new feature baked into iOS that was previously a domain ruled by third-party apps like its new HealthKit platform and Health app in iOS 8, questions inevitably come up about how it will impact other developers and competing platforms. That’s why we were interested in finding out how some of the top fitness and health app developers and accessory makers are reacting to Apple’s HealthKit announcement.

We reached out to some of the big names in the health and fitness app world, as well as companies like Withings and iHealth that sell iOS-connected health and medical accessories such as blood pressure monitors through Apple stores. Not only did all of the companies we spoke with— RunKeeper, Withings, Strava, and iHealth— confirm they are already planning integration with their ecosystems, they also talked about how having one central location for users to manage health and fitness data will indeed be a good thing for the business.

RunKeeper CEO Jason Jacobs told me he’s excited that Apple is bringing “some of the other key players in the ecosystem (doctors, EMRs, etc) into the discussion” and confirmed both his RunKeeper and Breeze app will soon support Healthkit. Others are also excited for integration with the medical industry that currently uses a highly fragmented record keeping system for health data.

Here’s what they had to say: Read more

iPhone app screens for skin cancer more accurately than your doctor, shows early testing

skin

Early testing of an iPhone app developed to detect melanoma – the most dangerous form of skin cancer – found an accuracy rate of around 85 percent. This is similar to that achieved by specialist dermatologists, and more accurate than examination by primary care physicians.

Melanoma, usually caused by too much exposure to the sun, is responsible for around three-quarters of all skin cancer deaths. It’s dangerous because it can spread quickly if not caught at an early stage, but surgery has a high success rate if the condition is detected and treated soon after symptoms appear …  Read more

iWatch’s novelty emerges as Apple taps sensor and fitness experts

Apple’s Tim Cook, Bob Mansfield, Kevin Lynch

Apple’s Tim Cook, Bob Mansfield, Kevin Lynch

Apple has begun assembling a team of hardware and software engineering, medical sensor, manufacturing, and fitness experts, indicating the company is moving forward with a project to build a fitness-oriented, sensor-laden wearable computer, according to our sources.

Over the past half-decade-or-so, Apple has experimented with and shelved numerous wearable computer designs. Internal prototypes have included designs that could clip onto different pieces of clothing (like an iPod shuffle/nano) in addition to devices that could wrap around a wrist.

Based on comments from Apple CEO Tim Cook and numerous reports, the wrist is the part of the body in which top Apple executives are currently targeting…

Read more

FDA begins cracking down on medical diagnosis apps starting with ‘uChek’ iPhone urinalysis app

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Bloomberg reports the U.S. Food and Drug Administration is launching a first of its kind inquiry into medical diagnosis apps starting with the ‘uChek’ urine analysis app from Biosense Technologies. The free app, which is currently still on the App Store, requires users to purchase a kit containing urine test strips that can be visually analyzed with the iPhone’s camera. The problem, according to a letter sent to Biosense from the FDA, is the fact that the test strips have only been cleared for “direct visual reading” and not automated analysis from an application:

Please note that though the types of urinalysis dipsticks you reference for use with your application are cleared, they are only cleared when interpreted by direct visual reading.  Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader.  When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system.  Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).

While Biosense plans to work with the FDA to resolve the issue, Bloomberg notes that this is only the start of a broader crack down on apps that claim to diagnose medical conditions: Read more