EAST HANOVER, N.J. – Novartis collaborated with video games developer Numinous Games on the Galaxies of Hope mobile app for people with neuroendocrine tumors. The app engages users through visual storytelling, using the actual words and voices of patients, caregivers and physicians who are part of the NET cancer community. “At Novartis, our vision is to reimagine how we can provide new platforms for patient support,” said Ameet Mallik, executive vice president and head of U.S. Oncology at Novartis, in a statement. “We believe that this app can have a real, positive impact in the NET cancer community.” Through the app, users can explore the different galaxies within the journeys to connect with the experiences of patients, caregivers and physicians involved in the NET patient journey.
CHARLOTTESVILLE, Va. – A smartphone app designed to improve care for people living with HIV has increased users’ consistency in doctor visits and improved their health outcomes, a new study has found.
Users of the PositiveLinks app intervention developed at the University of Virginia School of Medicine showed improved consistency in doctor visits at both six and 12 months, and the percentage of people with “undetectable HIV viral loads”—a key outcome for individuals living with HIV—increased significantly.
The PostiveLinks app features a mix of engagement, social interaction and access to care providers, and provides appointment reminders, important health information and daily questions about stress, mood and medication adherence. It also features a virtual support group where users can interact anonymously to ask questions, share their stories and find strength in the journeys of others.
UVA created the app to address serious health care gaps for people living with HIV, as nearly half of people diagnosed with HIV never establish regular care, said Dr. Rebecca Dillingham, one of the study’s researchers, in a statement.
“PositiveLinks was developed with significant input from our patients for the entire duration of the project,” said Dillingham. “We believe that this collaborative approach to creating and testing a clinical intervention made it more appealing to our patients and contributed to the terrific outcomes.”
The researchers are continuing to improve the app and have already rolled it out to serve more than 200 patients at UVA. They are also replicating the program at the Inova health system in Northern Virginia as well as in Lynchburg, Va. It’s also being used in Irkutsk, Russia, to support people co-infected with HIV and tuberculosis.
CHARLOTTE, N.C. – SensorRX, a provider of patient generated health data, has acquired Welltodo, developer of the iPhone application Migraine Coach. The app features iterative design principles and an algorithmic approach to tracking migraine headaches. “This is a win for migraine and chronic disease sufferers alike,” said Chris Cardinal, co-founder and CEO of Welltodo, in a statement. “SensorRX’s partnerships with health care systems, resources and talented leadership will move us toward our ultimate goal of leveraging data and technology to reduce the burden that chronic disease places on individuals’ lives and on business’ bottom line.” SensorRX is the developer of the mobile app MigrnX, a migraine tracking system that integrates with enterprise electronic health record vendor systems to improve patient care. It was developed with assistance from the Texas Medical Center Innovation Institute’s accelerator program and tested within Carolinas Healthcare (now Atrium Health). Migraine Coach users will be integrated into MigrnX immediately.
WASHINGTON – Home health technology industry leaders believe the U.S. Food and Drug Administration’s proposed regulation around mobile medical apps is a step in the right direction.
“With the significant increase in the adoption of mobile health care apps, it is necessary to have regulated guidelines and the oversight to ensure the safety and effectiveness of medical devices—including mobile medical apps,” said Leena Palav, senior vice president and chief compliance officer at AMC Health, a provider of remote monitoring solutions. “But in order for these regulations to have the greatest impact, we need to ensure that the digital health guidelines are not released in isolation because this can be confusing to the industry.”
Dr. Scott Gottlieb, FDA Commissioner, said in a viewpoint published this month in JAMA that regulation can encourage development and utilization of mobile medical apps. He said that the health care industry has historically been slow to implement disruptive technology tools, in part because of uncertainty surrounding regulation.
To address the issue, the agency released a Digital Innovation Plan last year, which included plans for a pilot program that would allow makers of low-risk software-based medical devices to self-certify their products and avoid the traditional premarket review process. Nine companies including Apple, Fitbit and Johnson & Johnson were selected to participate in the pilot, which is expected to start next year.
The FDA also announced plans to not regulate mobile apps intended to maintain or encourage healthy living.
“For the sake of patient safety, we believe any digital solution used to diagnose and/or treat a medical condition should be held to a regulatory standard,” said Larissa D’Andrea, senior director of government affairs at sleep solutions provider ResMed. “If done right, such regulation will instill greater patient and provider confidence in connected health solutions and encourage their adoption.”
WASHINGTON – The U.S. Food and Drug Administration says it’s willing to increase over-the-counter access to some medications to treat common and chronic conditions, if there are resources in place, like digital health technologies, to determine if the treatment is appropriate.
In a statement, Dr. Scott Gottlieb, FDA Commissioner, said the FDA’s approaches could include applying digital health technologies like mobile apps that would support consumers in appropriately and safely self-selecting and using certain drugs.
“While the FDA doesn’t have a direct role in the cost of medicines, we’re very mindful of the time and financial cost to patients and the health care system to fill a prescription medicine—particularly one taken repeatedly for chronic conditions,” he said. “Our hope is that the steps we’re taking to advance this new, more modern framework will contribute to lower costs for our health care system overall and provide greater efficiency and empowerment for consumers by increasing the availability of certain products that would otherwise be available only by prescription.”
The agency has drafted guidance that lays out a process whereby a sponsor—for example, a company that has a prescription drug—could develop a mobile app that increases the likelihood of correct self-selection and accurate use of the product in the nonprescription setting. After demonstrating through studies that consumers can safely use the drug without a prescription and with associated supervision of a health care professional, the sponsor could submit an application for FDA consideration for nonprescription status for the product.
“As we move into making this a reality, the FDA will ensure that products considered under this framework receive a robust scientific review to ensure they can be used safely by patients,” Gottlieb said. “Our ultimate goal with modernizing our regulatory framework for nonprescription drugs is to help facilitate a market that is more competitive, enables greater access to medical products, empowers consumers in their health care decisions, and provides more affordable options for Americans.”
SANTA MONICA, Calif. – Mindfulness and meditation app provider Headspace has formed Headspace Health, a new, wholly owned subsidiary that will incorporate the Headspace meditation experience into digital medicine. The new company plans to deliver a prescription meditation app in 2020 when it anticipates the introduction of the first product in its portfolio of newly developed, clinically-validated and FDA-cleared meditation programs specifically designed to treat a broad range of chronic diseases. “The creation of Headspace Health is the most significant step ever taken to introduce meditation into medicine at scale,” said Rich Pierson, co-founder and CEO of Headspace, in a statement. “By standardizing meditation into health care, we’re bringing Headspace even closer to realizing our mission of improving health and happiness around the world.” Headspace Health is scheduled to begin randomized controlled trials this summer on its first targeted disease state, to be announced in the coming months. The completion of clinical trials and subsequent FDA submission are scheduled for 2020, with the goal of making Headspace Health’s initial prescription meditation program available to doctors. Headspace Health will be led by Dr. Joe Powers, as managing director.
NEW YORK – Oshi Health has introduced a mobile app for people with inflammatory bowel disease. The Oshi app features symptom tracking, curated learning and expert Q&A. “Oshi empowers individual control and understanding of IBD wellness,” said Daniel Weinstein, CEO of Oshi Health, in a statement. “The Oshi app has the potential to significantly improve lives with smart tools to manage and control Crohn’s disease and ulcerative colitis.” The all-in-one app features: educational content; symptom tracking; integration with fitness devices, sensors and wearables; and notifications.
LOS ANGELES – Researchers at the University of Southern California Viterbi School of Engineering have developed a method for measuring arterial stiffness with a smartphone app.
Arterial stiffening, in which arteries become less elastic and more rigid, can result in increased blood and pulse pressure. In addition to being a known risk factor for cardiovascular diseases, it is also associated with diseases like diabetes and renal failure.
By measuring pulse wave velocity, which is the speed that the arterial pulse propagates through the circulatory system, clinicians are able to determine arterial stiffness. Current measurement methods include MRI or tonometry, which requires two pressure measurements and an electrocardiogram to match the phases of the two pressure waves.
The app the researchers developed uses a single, uncalibrated carotid pressure wave that can be captured with a smart phone’s camera. Instead of a detailed waveform required with tonometry, the smartphone app needs just the shape of a patient’s pulse wave for the mathematical model, called intrinsic frequency, to calculate key variables related to the phases of the patient’s heartbeat. These variables are then used in a machine learning model that determines pulse wave velocity and, therefore, arterial stiffness.
To validate their method, the researchers used existing tonometry data collected from the Framingham Heart Study, a long-term epidemiological cohort analysis. Using 5,012 patients, they calculated their own PWV measurements and compared them with the tonometry measurements from the study, finding an 85% correlation between the two.
“What the clinician wants to know is whether or not you’re helping them to improve outcome,” said Niema Pahlevan, one of the researchers. “And we showed that our app is as predictive as the actual tonometry.”
The team plans on expanding on the intrinsic frequency algorithm so that it can be applied to a number of other applications, such as detecting silent heart attacks.
PARSIPPANY, N.J. – Ascensia Diabetes Care has launched an upgraded version of the Contour Diabetes app, featuring My Patterns, which uses algorithms to more intelligently analyze blood glucose results received from the Contour Next One meter and deliver meaningful feedback to patients. “The My Patterns feature on the new Contour Diabetes app represents a real advance in the use of data for diabetes management,” said Michael Kloss, CEO of Ascensia Diabetes Care, in a statement. “This can help people with diabetes stay on track between visits to their doctor and can provide meaningful information for more informed consultations.” Once it has notified the user that a sub-optimal pattern has been identified, the app prompts them about the possible causes of the pattern and provides guidance to help address it. It allows patients to set reminders or use testing plans to help improve their blood glucose patterns and tracks their progress to see if the pattern improves over time. The latest version of the app includes the ability to recognize 14 different patterns and use 11 different structured testing plans.
BALTIMORE – Computer scientists at Johns Hopkins University have developed a way to manage the varying severity of Parkinson’s disease symptoms by using a smartphone app, according to a study published recently in the online journal JAMA Neurology. The app uses sensors to generate a score that reliably reflects the symptom severity. Patients can use the app to monitor symptoms in their home and share this data with their doctor to help fine-tune their treatment. “If you think about it, it sounds crazy, but until these types of studies, we had very limited data on how these people function on Saturdays and Sundays because patients don’t come to the clinic on Saturdays or Sundays,” said E. Ray Dorsey, a co-author of the research paper, in a statement. “We also had very limited data about how people with Parkinson’s do at 2:00 a.m. or 11:00 p.m. because unless they’re hospitalized, they’re generally not being seen in clinics at those times.” Using existing smartphone components, such as its microphone, touch screen and accelerometer, the team members devised five simple tasks involving voice sensing, finger tapping, gait measurement, balance and reaction time to create the app. Using a machine learning technique that the team devised, they were able to convert the data collected with these tests into an objective Parkinson’s disease severity score—a score that better reflected the overall severity of patients’ symptoms and how well they were responding to medication. This smartphone evaluation, the researchers say, should be useful because it doesn’t rely on the subjective observations of a medical staff member. It can also be administered any time of day in a clinic or within the patient’s home, where the patient is less likely to be as nervous as in a medical setting. “Not all research gets integrated tangibly into people’s lives,” said Srihari Mohan, another researcher, in a statement. “What excites me most is the potential for the methods we developed to be deployed seamlessly into a patient’s lifestyle and improve the quality of care.”