Report: VA in talks with Apple to move EHRs to iOS devices

US Dept. of Veterans Affairs, Apple

The U.S. Department of Veterans Affairs could be partnering with Apple (NSDQ:AAPL) to bring electronic health records to iOS-based smartphones for military veterans across the country, according to a Wall Street Journal report.

Through the deal, Apple would build out software that would allow the approximately nine million veterans in the country to transfer their health records to their iPhone devices, according to the report. Apple would also be positioned to supply engineering support to the agency.

The information comes from a number of emails between top VA officials and associates of President Donald Trump’s Mar-a-Lago club, reviewed by the Wall Street Journal, according to the report. Apple has not yet officially commented on the matter.

The move is yet another step from the Cupertino, Calif.-based tech giant as it looks to pry its way into the healthcare market. Earlier this month, an atrial fibrillation screening study using Apple’s next-gen Apple Watch enrolled 400,000 subjects, making it the largest study of its kind to date.

In June, Apple opened up its Health Records application to developers, allowing digital health companies to use electronic health record data to power applications on Apple’s iOS devices.

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Apple Watch study enrolls 400k participants

Apple Watch

An atrial fibrillation screening study using Apple‘s (NSDQ:AAPL) next-gen Apple Watch has enrolled 400,000 subjects, making it the largest study of its kind to date.

Enrollment for the Apple Heart trial has been completed by Stanford University’s School of Medicine, and the study rationale and design has already been published in the American Heart Journal.

“The advantage of the app that uses the optical sensor is that it can check for an irregular pulse multiple times throughout the day in the background, without needing the user to actively engage the application,” study principal investigator Marco Perez of Stanford’s Cardiovascular Medicine said in a prepared statement.

Investigators in the trial aim to explore whether wearable technology can successfully identify pulse irregularity, in hopes that it may be able to identify previously unknown atrial fibrillation. The watch analyzes pulse-rate data with an optical sensor, using LED lights and light-sensitive photodiodes to measure changes in the volume of blood flowing through the users wrist.

If atrial fibrillation is detected, participants will be alerted through a notification system on the Apple Watch or Apple Heart application. Subjects will then proceed through a telehealth video visit with a doctor and receive an electrocardiogram monitoring patch to confirm the AF diagnosis.

Any participants who experience urgent symptoms will be directed to their local urgent care or emergency room facilities.

“We now have access to high-quality sensors that can measure and detect changes in our bodies in entirely new and insightful ways without even needing to go to the doctor, but we need to rigorously evaluate them,” study principal investigator Mintu Turakhia of Stanford’s Cardiovascular Medicine said in a press release.

Last month, Zimmer Biomet (NYSE:ZBH) said that it launched a clinical trial using the Apple Watch to help hip and knee replacement patients that could enroll as many as 10,000 patients.

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NYT Report: Apple Watch ‘should not be considered a medical device’

The new electrocardiogram-equipped Apple (NSDQ:AAPL) Watch should not be considered a medical device, according to a new report from the New York Times.

The article, written by Indiana University School of Medicine pediatrics professor Aaron Carroll, calls into question the downsides of the newly released device and the potential for both false positives and false negatives.

Carroll acknowledged the possible positives of the device, including the ability for physicians to monitor patients from a distance and diagnosing heart problems in individuals that would possibly go undetected, but said that “just because something seems like a good idea doesn’t mean it is.”

“No screening test is perfect,” Carroll wrote in the Times article. “In general, we would like people who are sick to have a positive screening result, and people who are well to have a negative result. Unfortunately, people who are sick sometimes have a negative result. Those are false negatives. People who are well sometimes have a positive result. Those are false positives.”

Both outcomes are worrisome, Carroll suggested in the report. He added the false negatives may cause someone who needs medical help to not seek it, but said that because “relatively few people have serious, undiagnosed arrhythmias with no symptoms” that it wasn’t a major concern.

False positives, however, end up costing time time, money and emotional distress, according to the Times report.

“The health care system is already busy, if not overloaded. No physician wants to field calls from patients who have no problems. Such patients will require visits and further testing, and will potentially receive interventions. They’ll generate bills and harms without benefits,” Carroll wrote.

Carroll said that the watch’s “irregular rhythm” notification feature is likely to generate “many false positives.” He added that before the watch won clearance, the FDA reviewed data collected by the Stanford Heart study for 266 individuals who received irregular rhythm notifications, and said that most of them had been wrong.

“The study wasn’t peer reviewed, so we don’t know for sure, but this was also a population for whom atrial fibrillation might be more common than in those who might use the watch. People who buy the latest Apple watch will most likely be younger, healthier, wealthier and more plugged into the health care system – and less likely to remain undiagnosed,” he wrote for the Times.

He went on to suggest that one of the major problems with the device is that the people who would benefit most are least likely to get it, according to the report.

“If we truly believed this was a medical test beneficial to the general population, insurance should pay for it. No one is suggesting that should happen,” Carroll wrote for the Times.

He went on to suggest that experts generally aren’t in support of universal cardiac monitoring, and that the US Preventive Services Task Force issued a “D” recommendation for screening asymptomatic adults at low risk, according to the report.

The suggestions were based on good research, Carroll said in the Times article. He added that a randomized controlled trial of ECG screening for heart problems “did not demonstrate that such screening offered any benefits in reducing desk or the risk of heart attacks or stroke in middle-aged people,” and that the ECG scans were “much more robust” than the Apple Watch will provide.

“I happen to own an Apple Watch. I find the other functions useful and fun. I even enjoy aspects of the activity monitoring. But I’m under no illusion they will help me lose weight or exercise more or improve my heart health. I own one because I want it, not because I need it. That’s the same criterion you should use, too,” Carroll wrote.

Last month, Apple unveiled the Series 4 Watch, which features on-board electrocardiogram scanning technology.

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Report: Apple is exploring custom health sensor tech

Apple (NSDQ:AAPL) may be looking to develop its own health sensor chip technology, according to a new report from CNBC.

The tech giant posted a job opening in mid July looking for “sensor ASIC architects to develop ASICs for new sensors and sensing systems for future Apple products,” according to the report.

A separate posting from August showed that Apple is looking for someone to “help develop health, wellness, and fitness sensors,” according to CNBC. An additional earlier posting from June mentioned that the company was also looking to continue working with optical sensors, which the company currently uses to measure heart rate.

Currently, Apple uses sensor-connected technology from Broadcom in its Apple Watch product, but may be looking to develop its own chip as a way to protect its IP from third-party developers, according to the report.

The hires don’t absolutely point to new tech, however, and could be related to the company’s existing biosensor technology, according to CNBC.

Apple has not officially commented on the matter.

In June, Reports emerged showing that Apple had submitted a patent application for a wearable blood pressure monitoring cuff.

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Apple opens EHR data to iOS app developers

Apple (NSDQ:AAPL) this week opened up its Health Records application to developers, allowing digital health companies to use electronic health record data to power applications on Apple’s iOS devices.

The Cupertino, Calif.-based tech giant originally opened the Health Records application for general use in March, allowing users of certain cooperating healthcare systems direct access to their electronic health records.

With the new Health Records API release, developers will now be able to use that electronic health data – with an individual’s consent – to create applications that aid in disease management, medical research and other purposes, the company said.

Medisafe, a medication management application, will use integrated EHR data to allow users to import their prescription list without the need for manual entry, identify problematic drug-drug interactions, set reminders and view applicable medication data.

“Medical information may be the most important personal information to a consumer, and offering access to Health Records was the first step in empowering them. Now, with the potential of Health Records information paired with HealthKit data, patients are on the path to receiving a holistic view of their health. With the Health Records API open to our incredible community of developers and researchers, consumers can personalize their health needs with the apps they use every day,” COO Jeff Williams said in a press release.

Health Records data is encrypted on iOS devices, Apple specified, and allows users to share data directly with selected trusted applications, without the data leaving the device.

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HRS 2018 Roundup: Device-related blood clots with Boston Scientific’s Watchman implant

Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.

There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.

Lead author Dr. Vivek Reddy, of New York’s Mt. Sinai Hospital, told MassDevice.com that the overall incidence of DRT for Watchman in the study was 3.7% using the FDA-approved strategy for anti-coagulation drugs. The surprise, Reddy told us, was the high rate of ischemic stroke in the DRT population.

“It’s surprising, not from a patho-physiological conceptual perspective, but it’s surprising because when we looked at this very early in Protect AF, again a small number of the patients in a relatively small follow-up, we did see that the subsequent stroke rate was a little bit higher, but certainly nothing like this,” he said. “We knew it was important, we knew that you had to do surveillance, we knew that if you see it you need to treat it, but we didn’t expect it to be this high.

“I think what this tells me, is that one has to be aggressive about dealing with device-related thrombus,” Reddy said, noting that it’s less clear how to proceed over the long term than in acute cases.

“It’s pretty clear how you treat it acutely – you give anticoagulation and let it dissolve,” he explained. “What’s less clear, though, is what do you do long-term after that. I think that what I would recommend, not that we have definitive data on this yet, but what I would recommend is aggressive surveillance in those patients who had device-related thrombus. I would recommend that some of them will probably require longer-term anticoagulation. That’s my guess.

“These data I don’t think take away from the argument that Watchman is a reasonable strategy. It doesn’t add or detract from the previous data. What it does do though is, I think it hones in and says when you have this you have to treat those patients aggressively,” Reddy told us.

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Google, Fitbit ink collab healthcare deal, look to challenge Apple Watch

Fitbit (NYSE:FIT) yesterday announced plans for a health-care collaboration with Google (NSDQ:GOOG), giving Apple (NSDQ:AAPL) and its Apple Watch more competition in the mobile health monitor market.

The wearable developer plans to use Google’s Cloud healthcare API for further healthcare system integration, which could allow FitBit activity data to be integrated with electronic medical records for more personalized care, Fitbit said.

“Over the past decade, we have built an incredible foundation as the leading wearables brand, helping millions of people around the world make lasting behavior changes that improve their health and wellness through fun and engaging experiences. Working with Google gives us an opportunity to transform how we scale our business, allowing us to reach more people around the world faster, while also enhancing the experience we offer to our users and the healthcare system. This collaboration will accelerate the pace of innovation to define the next generation of healthcare and wearables,” Fitbit co-founder & CEO James Park said in a prepared statement.

Both companies will also aim to improve management for chronic conditions, including diabetes and hypertension, through the use of services like Twine Health, which Fitbit recently acquired. Fitbit said that using the cloud platform will also allow it to scale more quickly and more properly protect user privacy.

“At Google, our vision is to transform the way health information is organized and made useful. By enabling Fitbit to connect and manage key health and fitness data using our Google Cloud Healthcare API, we are getting one step closer to this goal. Together, we have the opportunity to deliver up-to-date information to providers, enhancing their ability to follow and manage the health of their patients and guide their treatment,” Google Cloud healthcare VP Dr. Gregory Moore said in a press release.

Last month, the American Medical Association said it would partner with Google to launch the AMA Health Care Interoperability and Innovation Challenge designed to support mobile health technology that improves monitoring and care in the management of chronic diseases.

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Medtech’s existential crisis and how it can survive

The new EY report even includes an equation to show how medtech and other life science companies will need to deliver value: “Future value (FV) is driven by innovation (I) that focuses on outcomes with a high degree of personalization and is fueled
by unlocking the power of data (D.” [Image courtesy of EY]

Executives in medtech and other life sciences companies view digital health startups and high tech giants as an existential threat. To compete, they’re going to have to invest in or acquire customer engagement and personalization skills usually associated with online retailers and social networking sites, according to a new report out today from EY.

The report — Life Sciences 4.0: Securing value through data-driven platforms — quotes Johnson & Johnson CEO Alex Gorsky to indicate where things are going:  “Technology will touch everything that we do, whether it’s the way we use data to better understand the genome … or as it applies to things like minimally invasive surgery, even the way we talk to consumer vis-à-vis social media.”

Technology isn’t the only factor driving the change. Aging populations in the developed world mean that both public and private payers are tackling budgetary constraints and longstanding inefficiencies in healthcare systems.

In the medical device industry, companies are having to decide whether they are products companies selling to health providers or services companies focused on patients as a customer, according to the report’s author, Pamela Spence,  EY Global Life Sciences industry leader.

“I think companies need to decide what they want to be. … It’s hard to do both,” Spence said during an interview with our sister site Medical Design & Outsourcing.

Get the full story on MDO. 

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Apple continues its foray into healthcare, puts select EHR data on iPhone devices

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Apple (NSDQ:AAPL) said this week it is introducing a feature allowing customers to obtain, view and keep medical records on their iPhones, continuing the company’s experimentation into the healthcare market.

Electronic health records will be available within the company’s Health application, with 12 different healthcare organizations already agreeing to make their records available to current customers.

Records viewable on the mobile devices were created based on Fast Healthcare Interoperability Resources standards, the Cupertino, Calif.-based company said. Medical data stored on iPhone devices are encrypted and protected with the user’s iPhone passcode, Apple said.

“Our goal is to help consumers live a better day. We’ve worked closely with the health community to create an experience everyone has wanted for years — to view medical records easily and securely right on your iPhone. By empowering customers to see their overall health, we hope to help consumers better understand their health and help them lead healthier lives,” Apple COO Jeff Williams said in a press release.

Participating medical institutions include Baltimore’s Johns Hopkins Medicine, Los Angeles’ Cedars-Sinai, Philadelphia’s Penn Medicine, Danville, Penn.’s Geisinger Health System, San Diego’s UC San Diego Health, Chicago’s Rush University Medical Center, Dignity Health, Jefferson Parish, La.’s Ochsner Health System, MedStar Health, Columbus, Ohio’s OhioHealth and Kansas City’s Cerner Healthe Clinic, Apple said.

“Streamlining information sharing between patients and their caregivers can go a long way towards making the patient experience a positive one. This is why we are excited about working with Apple to make accessing secure medical records from an iPhone as simple for a patient as checking email,” Johns Hopkins Medicine CIO Stephanie Reel said in a prepared statement.

“Putting the patient at the center of their care by enabling them to direct and control their own health records has been a focus for us at Cedars-Sinai for some time. We are thrilled to see Apple taking the lead in this space by enabling access for consumers to their medical information on their iPhones. Apple is uniquely positioned to help scale adoption because they have both a secure and trusted platform and have adopted the latest industry open standards at a time when the industry is well positioned to respond,” Cedars-Sinai CIO Darren Dworkin said in prepared remarks.

Last month, Apple was reported to be developing an in-house ECG for its Apple Watch that would compete with the recently approved KardiaBand made by AliveCor.

Report: Doctor self-diagnoses cancer while testing Butterfly iQ ultrasound

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Butterfly iQ

A vascular surgeon was able to diagnose his own cancer while testing the Butterfly Network’s Butterfly iQ ultrasound-on-a-chip device, according to a report from USA Today.

After experiencing some throat discomfort Dr. John Martin self-tested the device, designed to send images to and operate in conjunction with Apple (NSDQ:AAPL) iPhones, and found a mass that he thought looked cancerous, according to the report.

The mass turned out to be squamous cell cancer which Martin has since received treatment for, including surgery and radiation therapy.

“I felt something funny in my neck, connected the probe to my phone, did an ultrasound, and there it was: My tumor,” Martin said, according to USA Today.

The Butterfly iQ device won FDA 510(k) clearance earlier this month with 13 clinical indications, which the Guilford, Conn.-based company touts as the “broadest every for a single ultrasound transducer.”

Butterfly said its device consists of a single wide-band, 2D matrix array with thousands of microelectromechanical systems overlaid on an integrated circuit.

The company touted that the cost of the device was significantly lower than existing technology, saying it could reduce costs between 10 to 100 times.