How is medical device interoperability regulated? And, when it comes to mobile health apps, what should be regulated?
As medical devices converge with wireless technologies, the FCC along with the FDA is beginning to take an active role in regulating mobile health and device interoperability. This relationship between the two agencies was discussed at this week’s AdvaMed 2015 conference in San Diego.
The fact remains, after all, that the government must provide regulatory oversight for medical devices that communicate remotely – to preserve users’ privacy and security, and to ensure these devices actually work. And it’s a constant question over what should be regulated, and what should not.
“We make choices about which products to scrutinize, and which to not scrutinize,” said Bakul Patel, associate center director for digital health at FDA. “That comes from the inherent heterogeneity of medical devices.”
Back in March 2013, Research2Guidance counted in the neighborhood of 100,000 health, fitness and wellness apps in the Apple App Store and Google Play. That number almost certainly has increased since then.
Today, consumer health engagement company HealthMine said that while 64 percent of Americans own smartphones, just 18 percent of the general population enjoy learning health, wellness and lifestyle information via mobile apps. That’s based on a survey of 1,200 people by the Dallas-based company.
And then comes the money quote from the HealthMine press release: “Mobile health is still far from broad engagement—unless you are sick.” That’s because another HealthMine survey of 509 people with diabetes or pre-diabetes from August found that 42 percent manage their condition with mobile blood-sugar monitors, while 39 percent use mobile monitors for blood pressure.
Scanadu CEO Walter De Brouwer played digital health provocateur during a talk at this week’s Transforming Medicine: Evidence-driven Mhealth conference at Scripps Translational Science Institute. The future of healthcare involves commoditizing the patient. Or rather, as he put it, the consumer.
Some background: Scanadu is developing a Jetsonian device that monitors bodily functions and vital signs; it relied initially on crowdfunding to kick off production. So, given the company’s forward-looking bent, De Brouwer highlighted the following concepts that he projects will be important over the next five years:
One of Thomas Insel’s most dramatic initiatives as the government’s mental-health research czar was to try to throw out the psychiatrists’ bible, the Diagnostic and Statistical Manual of Mental Disorders, or DSM (see “NIMH Will Drop Widely Used Psychiatry Manual”).It bothered Insel, who has been head of the National Institute of Mental Health in Bethesda, Maryland, since 2002, that unlike AIDS or lymphoma, mental illness is still diagnosed on the basis of clusters of symptoms rather than “any objective laboratory measure” such as a biomarker or readout.
Joslin Diabetes Center is running a small trial to pilot test a mobile health app and an online nutrition education platform for people with Type 1 diabetes, according to a ClinicalTrials.gov posting.
The web platform will help educate patients about how to optimize their glucose and analyze their after-meal behavior. The app will facilitate data logging to help patients and caregivers track and explain variability in their glucose readings. The system is called “Sugar Sleuth”.
The study will be a 3-month, 30-person, nonrandomized trial. The primary outcome measure will be blood glucose, measured in area under the curve.
Joslin is no stranger to digital health strategies for diabetes management. The medical center added a digital health division, called the Joslin Institute for Technology Translation (JITT) last June, and announced a partnership with Dexcom
Health is a big deal for Google. Two of its Alphabet companies are devoted to it. One of them, Life Sciences, recently named diabetes as its inaugural area of focus with other widespread diseases to come. Google’s co-founders (and Alphabet chiefs) are obsessed with massive, intractable medical problems.Yet the company has given minimal disclosures on its nascent, multi-pronged initiatives in health care. Still, one investment bank believes Google’s efforts — which include inventions like its smart contact lens and miniature diabetes monitor, as well as its venture investments — could create its next multi-billion dollar business. In a sizable research note published last week, Cowen and Company wrote that Google’s moves “represent significant unlocked value” that will start becoming clearer as the company separates the finances of Google and Alphabet in the fourth quarter.
As part of the continued push for ways to aggregate digital health data, Philips Healthcare has unveiled an app for people with Type 1 diabetes, according to a company statement. Its debut at the Dreamforce conference this week is part of a move by Philips to expand its personal health information offerings and makes use of the recently launched Salesforce app cloud
Its app, developed with Dutch Radboud University Medical Center, provides a way for patients to track blood glucose levels, insulin use, nutrition, physical activity, mood and stress and get data-driven feedback and coaching guidance.
That description could apply to several apps on the market that have at least a year up on Philips move, such as My Sugr, which is one of the most popular apps for people with diabetes.
The break-fix model of medicine is now being replaced with the predict-and-prevent model of medicine that combines cutting-edge technology with detective work, and addresses the root of afflictions while staving off future issues by encouraging lifestyle and behavioural changes, and preventative practices.
As the mobile health industry continues to progress and new innovations impact patient care, regulatory agencies are taking part in greater oversight of mHealth apps, wearable devices, and remote monitoring tools. From ensuring mobile apps are safe for use among patients to developing new reimbursement policies for healthcare providers offering telemedicine services, federal agencies are driving forward patient engagement and security in the mobile health industry.The Food and Drug Administration (FDA) in particular plays a significant role in regulating the mobile health industry. According to a report released by the FDA called FDA's Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology, the organization’s medical device regulatory program “is performing strongly across a wide range of performance measures.”
In 2011, Ammar Siddiqui, a senior medical student at the Icahn School of Medicine at Mount Sinai in New York City, was volunteering in the East Harlem Health Outreach Partnership, a student-run clinic for uninsured patients. As the student overseeing referrals, he was overwhelmed by hundreds of daily emails from students asking questions -- from whom to call to refer a patient to a specialist to how to order a medical test, he recalled.To stem the tide of emails, Siddiqui built a website where students could find answers to their questions independently. That site grew into an app, developed by Siddiqui and several other medical students. Launched in June 2012, it laid out the clinic's often labyrinthine protocols, generally invisible to patients, in step-by-step fashion. With it, figuring out how to scan documents or order medical tests could be done with the tap of a finger. Soon, Siddiqui and his colleagues had built a generic version of their app, which they called CareTeam, and began delivering customized versions to a growing number of clinics at Mount Sinai Hospital as part of the East Harlem Software Company, which they incorporated this year.
Life360, the maker of mobile applications for iOS, Android and Windows Phone that help keep families connected, has acquired Chronos Mobile Technologies, a startup behind a number of mobile apps that passively collect data from users’ smartphones in order to highlight trends and connections between various behaviors. Terms of the deal were not disclosed, but Chronos had closed on a small seed round from Maven Ventures, Draper Associates and Major League Baseball earlier in 2015.
Chronos first made its debut at TechCrunch Disrupt SF 2012 with a simple time-tracking application of the same name designed by Stanford Business School grads Charlie Kubal, formerly of Pandora and Google, and Dylan Keil, previously a mechanical engineer.
The app itself was then designed to appeal to “quantified self” enthusiasts, who wanted an easier way to gather data about their activities, including things like how long they were at work, how long they slept, how much time they spent commuting, and more.
95 years after gaining the right to vote, The League of Women Voters are lobbying on the agenda of healthcare expansion which, for some, means looking to technology for solutions. Though past consumer electronic products haven’t proved favorable toward women—even though they are the majority users—the next generation of wearables hopes to change that.Teresa Wang, strategy manager at venture fund Rock Health says there’s been a recent growth in women’s health funding when it comes to tech products. “Investors are starting to see there is an incredible market opportunity, especially around fertility. We’ve seen a lot of companies around fertility tracking or smart breast pumps. Whether this space was historically ignored because investors weren’t comfortable or familiar with it, they’re now realizing women are willing to pay for it.”
Is mobile healthcare and health apps the future? “Mobile health, loosely defined as the practice of medicine and public health, supported by mobile devices is projected to be a 26 billion dollar industry by 2017!” With that one stat I would say the answer is YES. Here is a quick breakdown of the Mobile Health apps that are leading the way. Weight loss apps (50 million downloads) Exercise apps (26.5 million) Women’s health apps (10.5 million) Sleep & meditation apps (8 million) Pregnancy apps (7.5 million) Tools & Instruments apps (6 million Doctors are loving the health apps as well. 80% of physicians use smartphones and medical apps. 40% believe mHealth technologies can reduce the number of visits to doctors’ office. 93% believe that these apps can improve patient’s health.
Apple announced its watchOS 2 on September 9. One of the major selling points behind the Apple Watch has always been combining the smartwatch idea alongside health and fitness tracking. Is this selling point panning out? What technological trends are seen in the healthcare industry and mobile devices — and are they really making a difference for doctors and patients? Amidst the buzz, here is a sampling of some Apple Watch apps that actually might be revolutionizing the healthcare industry.
Even though FDA has issued guidance on mobile medical applications, many people in the field of wearables, remote monitoring technologies, and mobile health apps are still unsure of the regulator's take on specific requirements. So it was newsworthy when Leonard Sacks, associate director for clinical methodology in the office of medical policy at FDA, spoke at last week's "Mobile Health: The Power of Wearables, Sensors, and Apps to Transform Clinical Trials" conference, hosted by the New York Academy of Sciences and Medidata.
Sacks said that he and many at FDA are enthusiastic about the potential of mobile health technology, but emphasized that the large amount of data gathered must yield a clinically meaningful endpoint:
Obviously these technological devices are fun. We enjoy Fitbit, it gives us a little bit of immediate gratification. Some of them are cool . . . that’s not what FDA is interested in. We’re interested in making robust decisions on whether drugs are working properly for our patients. From the regulatory point of view, we have to be sure that these devices are reporting a meaningful clinical benefit. The important thing to realize is that the effect on a physiological measure doesn't guarantee a meaningful benefit to the patient . . ."
With the ongoing reforms in the healthcare industry, the high amount of technology implementations taking place, and the rising number of patients in need of services due to the burgeoning baby boomer generation, a large number of doctors claim to be experiencing burnout. Could mobile health tools help solve the problems associated with physician burnout?
A report from QuantiaMD, a subsidiary of Physicians Interactive, explains that many doctors today would not recommend going into the medical field to generations of the future. EHR systems and other medical technologies that take up time and money are the main reasons behind this trend of burnout. However, mobile health tools and telemedicine could potentially change this effect.
Today, doctors looking to incorporate telehealth technology and mobile health tools are looking to early adopters for advice on how to effectively transition to this new mode of healthcare delivery. Hospital systems are looking to implement telemedicine to increase referrals toward their organization.
The survey results show that 62 percent of doctors aren’t currently offering virtual visits to their patient population but would like to learn more about this practice. More than half – 57 percent – are interested in conducting video-based visits with patients. Additionally, 60 percent of respondents stated that if a nearby hospital offered video consultations with specialists, they would be more likely to refer their patient to that healthcare system.
There are now more than 165,000 mobile health apps available in the U.S., yet most continue to have limited functionality and barriers remain for connecting mHealth app data to providers’ clinical data, which hinders full adoption of mHealth into healthcare management, according to the findings of an IMS Institute for Healthcare Informatics study.
According to the IMS Institute’s recently released report about consumer-focused mHealth apps, the number of mHealth apps has nearly doubled in the past two years and almost a quarter of consumer apps are now focused on disease and treatment management, while two-thirds target fitness and wellness. Mental health apps led among disease specific apps, followed by diabetes.
For the study, researchers drew on IMS Health’s AppScript Score database and analysis of 26,864 apps available in the U.S. The study found that app connectivity has become a major focus for app developers, with one in ten apps now having some capability to connect to a device or sensor. This connectivity provides biofeedback and physiological function data from the patient and greatly extends the accuracy and convenience of data collection, according to the IMS Institute study.
As part of the study, the IMS Institute also interviewed healthcare provider executives on the role and status of healthcare apps.
Of the over 165,000 mobile health (mHealth) apps available in the Apple iTunes and Google Play (Android) stores, 36 are responsible for one-half of all downloads, based on IMS Institute‘s latest research into Patient Adoption of mHealth: Use, Evidence and Remaining Barriers to Mainstream Adoption published today.
Sure, it can beat Ken Jennings at Jeopardy, tell you about your city, and dream up recipes for delectable delicacies, but now, IBM’s Watson is doing something even more important than all previous capabilities combined — it’s finally getting closer to becoming your doctor. Last April, the century-old company launched IBM Watson Health, and now, it’s opened up a new office in Cambridge, Massachusetts, home to some of the best universities in the U.S., and some of the most impressive biotech and pharmaceutical companies as well. In the last few months, Watson has already expanded its scope to take on some of our most pressing health issues and diseases, including cancer and diabetes, and with this new establishment, it seems that the supercomputer will only be taking on greater responsibilities in the industry.
Forget Google Glass and that Fitbit you used to wear; the ultimate in wearable computing isn't worn on your body, but embedded within it. With chips physically inserted into your body either attached to nerves or placed into muscles or skin, a new form of synergy between human and computer can occur
Windows/OS X/iOS/Web: Your emotional state can vary throughout the day, and there are certain things that you may not even realize affect your mentality. Optimism keeps track of your mental health and helps you find those emotional triggers.The app is free, and it’s relatively simple to use. It includes four main tabs where you enter daily data:Core Data: Basic info about your mood and habitsStay Well Strategies: You record data about potential methods for staying healthy. Exercise, spending time outside, professional support, and so on.Triggers: You’ll enter potential emotional triggers or stressors: a lack of sleep, relationship problems, social events, etc.Symptoms: In this tab, you add a little more detail on how you feel: your level of irritability, sadness, guilt, poor concentration, etc.
Seeking deeper insight into epileptic seizures and their effect on the human body, Johns Hopkins' ResearchKit study will collect heart rate sensor and accelerometer data from Watch, gyroscope data from iPhone and dynamic user feedback to track a variety of biometric measurements during a seizure episode, according to a source familiar with the project. The iPhone and Watch apps, now in beta testing, are slated to go live on Sept. 18.While sensor readings are automated, like many current iPhone-based ResearchKit initiatives, other metrics are not so easily ascertained. Activating the test process and measuring lucidity, for example, require some form of direct user interaction, a steep demand considering the extremely stressful nature of a seizure event. To help participants complete individual sessions they are given physical cues to answer contextual onscreen survey questions via Watch's Taptic Engine. Alternatively, a caregiver might be able to initiate the testing process if present, the person said.
According to a new report out this morning from IDC, Apple is now the number two wearable maker, thanks to its Apple Watch, coming in just behind market leader Fitbit during the second quarter of 2015. And it’s a close race, the analyst firm found. Apple shipped 3.6 million units in Q2 2015, just 0.8 million units shy of Fitbit’s total 4.4 million units, the report states. Those figures mean that Apple now has nearly 20 percent of the wearables market, while Fitbit has just over 24 percent.
Across the industry, 18.1 million wearables shipped in the quarter, a huge 223.2 percent increase from the 5.6 million units shipped during the same quarter last year.
Even though Apple could be benefitting from early buzz around the Apple Watch, IDC still sees strong potential for the device to continue to increase its marketshare in the months ahead. The firm noted that Apple is just getting started with the Watch, having only reached 16 geographic markets to date with, and only now beginning to forge agreements with third-party retailers.
The healthcare industry is focused on improving patient care and health outcomes by garnering greater patient engagement and implementing new technologies to better track medical conditions, reduce medical errors, and potentially prevent more serious or life-threatening situations. Mobile health applications and mobile devices both play a role in bringing greater patient engagement across the healthcare spectrum.The mobile health field brings greater patient engagement as more individuals continue to use mHealth tools to track their fitness, nutrition plans, and treatment protocols. Developing effective state and federal policies around mobile health applications and devices is vital to ensure that patient safety is high within the mHealth field.
MocacarePalo Alto, California-based MocaCare, which has developed a device that tracks cardiovascular health, raised $2 million in a round led by JDM Mobile Internet Solutions with participation from EMB International and Atom Health Corporation. This brings the company’s total funding to $4 million to date.The device, called MocaHeart, scans the user’s fingertips to measure blood flow velocity and uses that metric to determine heart rate and blood oxygen levels. It also offers users a qualitative measure of users’ overall cardiovascular health, called the Moca Index, which the company says is correlated to blood pressure.
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