Digital health tools are becoming more prevalent across the country. We’ve seen a number of research hospitals conducting clinical trials with virtual therapies or apps, partnerships between big tech companies and physicians, consumer technology companies getting deeper into healthcare, and an evolution of policies and protocols to keep in step with digital health advances.
We’ve already covered all the provider-related news for the first quarter of 2016, the second quarter and the third. Here’s a round up of the biggest healthcare provider news in fourth quarter of 2016.
Taking a closer look at mobile apps
In a far cry from the previous comparison of digital health tools to “snake oil,” the American Medical Association is now openly embracing them, albeit with a healthy dose of discretion and some ground rules. During the AMA’s Interim Meeting in Orlando, the group approved a list of principles to guide coverage and payment policies that support the use of mobile health apps and devices. However, given the significant variance quality of digital health tools, the AMA cautioned for patients and physicians to hedge their enthusiasm by acknowledging that not all apps and devices are created equal.
In another demonstration of app acceptance, the American Medical Association, The American Heart Association, HIMSS and the DHX joined forces to create Xcertia, a collaborative to evaluate and improve the safety and effectiveness of mobile health apps. The goal of the group is to establish best practices in mHealth app development, officials say. Xcertia aims to create a framework to improve mobile development and will serve as a resource to help consumers and clinicians choose mobile health apps.
Dr. Dennis Ausiello, director of the Center for Assessment Technology and Continuous Health (CATCH) at Massachusetts General Hospital, says the smartphone is “the greatest medical device ever made”. As part of a talk at the Xconomy Forum in Boston, Ausiello spoke about some lessons learned from GlucoSuccess, the Apple ResearchKit project launched by CATCH.
“The thing that we learned was telling patients things they already know is not very helpful,” he said. “The average duration of Fitbit use is 6-8 weeks and then it goes from 90 percent use to 10 percent use. And if you look at the reason for that it’s because, you know, I kinda knew when I walked 10,000 steps or when I only walked 10 steps. And I keep getting that information over and over again.”
Conversely, GlucoSuccess aims to help patients learn how their behaviors affect their health. Participants track activity duration and intensity, diet information, blood glucose measurements, body weight, and waist size, as well as glucose readings and diet information. Using this data, GlucoSuccess has been able to provide users with insights into how their fitness and nutrition data relate to finger-stick blood glucose values.
A study by researchers at the Duke Clinical Research Institute, announced late in the quarter, is evaluating the use of a virtual physical therapy program for people recovering from total knee replacement surgery. The study, entitled Virtual Exercise Rehabilitation In-Home Therapy: A Research Study (VERITAS), is using an in-home, on demand virtual rehabilitative therapy program called Vera from San Diego-based digital healthcare company Reflexion Health.The study, which is now enrolling patients and will be carried out at six different sites in the US with about 300 participants, will look at how Vera compares to traditional in-home or clinic-based physical therapy. Vera, which is FDA-cleared, acts as a virtual assistant: it guides users through their prescribed physical therapy exercises and uses 3D monitors to measure and record each patient’s performance.
Mount Sinai Health System, which has been an early embracer of apps for patient services, launched an app with BioTime Subsidiary LifeMap. It is available on both iOS and Android, after initially launching to iOS only in June, The app, MountSinaiNY, offers patients a mobile portal to find centralized information and services. Patients can use the app to find doctors and facility locations, pay bills online, access the provider’s news and social media feeds, and they also have access to a menu that leads to other features for patients who have also downloaded the Mount Sinai’s version of Epic’s MyChart app, called MyMountSinaiChart.
Personal genomics startup Helix, which is developing a digital hub for all things related to DNA testing ranging from direct-to-consumer to doctor-ordered, announced several partnerships: the Icahn School of Medicine at Mount Sinai, National Geographic and ExploraGen will collaborate to deploy Helix’s genetic-testing service, which is powered by DNA sequencing giant Illumina. Additionally, the company secured an investment from Kleiner Perkins Caufield & Byers, and the company also recently announced a partnership with genetic information company Invitae.
Mount Sinai Hospital also agreed to work with startup Kaigo Health to provide its patients with an app that combines personal health coaching, chronic disease management, and telehealth. Mount Sinai will roll out the technology for patients in its OB-GYN, maternal health, cancer and urology departments to begin with, with other parts of the hospital to follow. Kaigo Health hires coaches who are healthcare professionals but not practicing doctors. Patients are connected to a coach through an app, and that coach will connect with them about things like medication adherence, diet, and exercise, as well as help them navigate their insurance and connect them to members of their care team — either by setting up appointments, or via HIPAA-safe texting or video communications.
NewYork-Presbyterian, another digitally-friendly health system in the state, formed an investment fund to drive growth of fledgling digital health companies. NewYork-Presbyterian has focused on advanced technologies for enhanced care delivery for years. The venture fund follows the 2014 launch of the NYP Innovation Center to implement cutting-edge technologies for both clinicians and patients across its hospitals and clinics.
The American Cancer Society is supporting research at the the Feinstein Institute for Medical Research (the research arm of New York’s Northwell Health system), which is working on an app to guide people living with prostate cancer through the treatment decision process.Since people diagnosed with prostate cancer usually face a variety of treatments –from immediate surgery or radiation or ongoing observation until risk increases – patients have to carefully consider the potential side effects of treatment, such as incontinence or impotence. The app, which can be used on a smartphone, tablet or desktop, leads the patient through the initial decision process and provides questions based on their choices, and then using an algorithm to match their preferences to a treatment option. From there, patients can email the results to their doctor and discuss their potential plans.
Toronto-based SeamlessMD, a company that has developed an engagement tool for surgery patients, is rolling out its offering at Saint Peter's Healthcare System in New Brunswick, New Jersey. Saint Peter's will tap SeamlessMD to create an app-based ERAS (enhanced recovery after surgery) program for its cesarean section patients. Eventually it will also expand the program out to patients recovering from major colon surgery, gynecologic surgery and other major surgeries.
The innovation arm of Brigham and Women’s Hospital partnered with efficacy-focused digital health company Evidation Health to collaborate on a project measuring the real life impact of digital health solutions on clinical and financial outcomes. The idea is to combine forces to develop methods of creating direct-to-patient trials of digital health solutions, leveraging the research capabilities of Brigham and Women’s with the digital tools of Evidation. Through the collaboration, Brigham and Women’s investigators can speed up clinical trials using digital health solutions. This builds on the hospital’s burgeoning Innovation Hub, which was launched in 2013 and fosters innovation, collaboration and translation of technology to improve care delivery.
Of course, the year hasn’t been kind to all digital health companies. Sotera Wireless, one of the earliest stalwarts of the digital health space, filed for Chapter 11 bankruptcy in a Southern California court, saying that it did not have enough funds to pay a wide range of debts. Mass Device first broke the news. The company said in a filing that it has about $2.4 million in cash and owes more than $13 million to creditors, including Silicon Valley Bank and Oxford Finance. Some of that debt is from legal fees associated with a trade secrets case leveled against the company by competitor Masimo, but the company has also failed to pay inventory suppliers Zhonghuan Hi-Tech Corp and Nortech Systems.
Can apps be diagnostic tools?
While health and medical apps may be helpful in making diagnoses, it seems they still haven’t caught up to doctors. In a new study published in JAMA Internal Medicine, a head-to-head competition between doctors and algorithmic symptom-checking apps, the real human doctors came out on top by a margin of more than two to one.
But that hasn’t stopped some app developers from trying. There is one such application that essentially elevates coughing into a smartphone into a sophisticated diagnostic tool has performed well again in a clinical study. Australian digital health company ResApp, which makes a smartphone-based tool for diagnosing respiratory conditions, reported 91 to 100 percent accuracy with the app in a study of 243 patients spanning six different respiratory conditions.
The company began its Smartcough-C pediatric trial, which will take place at the Cleveland Clinic, Massachusetts General Hospital and Texas Children’s Hospital. Eventually, the company hopes to integrate those algorithms into telehealth offerings as well as making them available for clinical use. The double-blind study will have diagnosis of pneumonia as a primary endpoint. The secondary endpoints will include diagnosis of upper respiratory tract infection, croup, bronchiolitis and asthma.
Researchers at the Mayo Clinic believe that there may be a relationship between voice characteristics and heart disease, meaning that doctors might someday use voice-analyzing software as a non-invasive, complementary diagnostic tool. The hospital system released results of a study carried out with Beyond Verbal, an Israel-based voice analytics company, that used a smartphone app to measure their voice signal prior to a coronary angiograph. The double-blind study, which included 120 patients (who were referred for the heart disease test) and corresponding controls, identified one voice feature associated with a 19-fold increased likelihood of coronary artery disease. The researchers also identified 13 voice features that were associated with coronary artery disease, with the strongest such feature observed when patients were requested to record their voice while describing a negative experience.
Consumer tech companies move to get deeper into healthcare
Through a Freedom of Information Act request, MobiHealthNews obtained emails between Apple and the FDA that suggest the two are working closely together on future regulated devices and guidelines. Since July 2016, Apple has been in discussions with the FDA about two FDA-regulated products in the cardiac monitoring space, and emails show the company is also working closely with the FDA to develop a regulated app for diagnosing Parkinson’s disease. Additionally, the FDA invited Apple to join an international task force focused on shaping this future regulatory framework. Apple executives quietly joined a working group within the International Medical Device Regulators Forum (IMDRF), a group of regulators, scientists, legal experts and physicians from the US, Canada, the European Union, Australia, China, Russia, and Brazil to pursue harmonization of the regulatory approach to standalone medical software.
In another bite of Apple news, Dr. Ricky Bloomfield, a doctor on the forefront of implementing both Apple HealthKit and Apple ResearchKit in his position as Director of Mobile Strategy at Duke University, will leave Duke to take a position on Apple's health team. A colleague of Bloomfield's broke the news on Twitter and Apple confirmed the news.
Meanwhile DeepMind, Google's UK-based AI subsidiary, signed a new agreement with the NHS after the pair's February deal was scrutinized over the amount and type of patient data Google would have access to. An investigative report by the New Scientist revealed that Google would have access to a huge trove of patient data without the patients' express consent, a potential violation of NHS information governance principles. With the new announcement, DeepMind is taking care to avoid a repeat of that situation with a host of new data protections.
The new agreement is a five-year partnership with the Royal Free London NHS Foundation Trust. It will be a deployment of DeepMind's Streams app, which helps doctors get information about their acute kidney failure patients – including blood tests– faster, which will enable faster diagnostics in situations where time is of the essence. Once the app gets through the Medicines and Healthcare products Regulatory Agency (similar to the United States' FDA), DeepMind plans to roll it out to NHS hospitals in early 2017. Then, they'll start to expand the app beyond just acute kidney failure.
Uber continues to see healthcare as a major area for growth, according to Lindsay Elin, head of Federal and Community Affairs at Uber. At a panel at the Connected Health Conference in National Harbor, Elin spoke about a partnership with health system MedStar (whose director of consumer health initiatives, Pete Celano, also attended), a new team of employees dedicated to health, and the expansion of several programs including working with Circulation, a startup that recently spun out of Boston Children’s Hospital.
Diabetes management increasingly digital
Always an expanding field in digital health, diabetes prevention tools and programs featured heavily in our 2016 coverage.
While the experts at Harvard's Joslin Diabetes Center have been happy with the results of their clinically-validated diabetes prevention program, they wanted to reach a larger population. Enter HealthyMation, a new healthcare animation studio that builds on the success of the brick-and-mortar program to deliver the company's first digital product: an app version of their popular DPP. Dr. Osama Hamdy, medical director of the Obesity Clinical Program at Joslin, assembled a team of digital health professionals, animators and video game developers to launch HealthyMation. The company launched last month but just recently opened up their first product to beta users: an app based on the clinic’s long-running DPP called the Weight Achievement and Intensive Treatment, or WhyWAIT?
Phoenix, Arizona-based Solera Health, which offers a platform that acts as an integrator for chronic disease management programs and services, announced the launch of new app to augment in-person delivery of diabetes prevention programs. Called SoleraONE, the app is designed for people who are participating in a community-based, in-person DPP. With the app, in-person DPP providers in the Solera network – which includes community based organizations, health systems, diabetes education programs and others – can offer their participants the best of both worlds. Participants of in-person DPP programs can use the app for times when they can’t physically attend their sessions, and they can also seek additional support to complement their in-person program with access to digital coaching and group interactions, nutrition help and activity tracking.
Telemedicine becomes more established
While gaining serious traction in most of the United States, telemedicine access still isn’t equal in every state. Texas and Arkansas, both states with policies that are esistant to adoption of virtual care, made our headlines regularly this year. Teladoc, which offers remote medical visits, sued the TMB in state court way back in April 2015, alleging that because the board was made up of practicing doctors with a financial interest in squelching telemedicine, the board's passing of anti-telemedicine legislation constituted a violation of antitrust laws. But the medical board filed a motion asking for the suit to be dismissed on the grounds that there is, in fact, state supervision of the medical board which would make it a state agency under law and therefore immune to suit. When the judge denied the motion, the medical board appealed to the Fifth Circuit court. Teladoc and the Texas Medical Board then asked for, and received, a stay in their ongoing lawsuit. The case will resume in Western Texas District Court on April 19, 2017.
The case, which concerns whether anti-telemedicine regulations levvied by the board constitute a violation of antitrust laws, was set to resume after the board withdrew an appeal to the Fifth Circuit court. But both parties filed a joint motion saying that "the Parties believe that it would be most efficient and cost effective to stay this proceeding for 150 days". Then, in an unusual move, the Texas Medical Board dropped its appeal in its case against Teladoc. The appeal itself was an unusual move, as the board appealed not the lower court's final decision, but its rejection of the state's motion to dismiss the case.
Arkansas is inching closer to the national standard of telemedicine allowances. The state’s Medical Board unanimously passed requirements allowing doctors to examine patients from afar through audio and visual technology, the Arkansas Democrat-Gazette reported. Patients and physicians must establish a relationship before a telemedicine visits, the rules state, and the relationship cannot be established if a patient only completes medical history forms online.
More and more monitoring solutions are out there, thanks to more devices. Mountain View, California-based AliveCor, which makes an FDA-cleared mobile electrocardiogram (ECG) device and companion app collectively called Kardia Mobile, has released new features that make it easier to integrate weight, activity, and blood pressure readings via Apple Health or Google Fit.The added features built on Kardia Mobile’s existing monitoring capabilities for atrial fibrillation, allowing users at risk for stroke to keep tabs on five indicators of cardiovascular disease: heart rhythm, blood pressure, weight, physical activity and resting heart rate. The FDA-cleared Kardia Mobile device takes the form of a smartphone case with two electrodes attached to the back. Users open the Kardia app, place their fingers on the electrodes, and describe out loud any symptoms they are having as the reading is taking place.
Telemedicine provider American Well teamed up with Israel-based medical device maker TytoCare to combine video telehealth visits with remote examinations. With the partnership, TytoCare’s examination platform will be integrated into American Well’s telehealth platform. In turn, TytoCare’s customers will have access to the network of healthcare providers who use American Well’s platform. Patients will be able to replicate an in-office visit at home by using TytoCare’s platform to examine the skin, heart, lungs, abdomen, ears, throat and skin. Then, they can share the examination with a clinician prior to or during a telemedicine visit.
CliniCloud, the Melbourne, Australia-based company that makes a connected stethoscope and thermometer to support telemedicine use cases, announced a partnership with New Jersey retail and concierge healthcare organization Astra Primary Care Associates. The partnership marks a new direction for CliniCloud, which has so far deployed its app and devices as an add-on to telemedicine services offered via payers, such as existing partner Doctor on Demand.
Vancouver, British Columbia-based Reliq Health, which develops mobile health and telemedicine products for Community-Based Healthcare, is working with UK National Health Services system on a pilot to explore remote patient-monitoring solutions. Now actively enrolling patients from the Imperial College Hospital in London, the pilot seeks to assess how Reliq Health’s platform can help improve health outcomes and cut down costs for people with chronic conditions after a hospital visit.
App-enabled “full stack health plan” Zoom+, which offers telemedicine, walk-in clinics, and health insurance as an integrated, tech-enabled offering in the Portland, Oregon area, has launched a new feature, Zoom+Care Chat. The new feature allows Zoom+ users to get medical advice and even prescriptions via secure messaging and, ideally, will increase convenience for patients while also reducing the number of patients Zoom+ clinics need to see.
Being the official hospital of an NFL team has its perks. A two-year pilot project using telemedicine to treat concussions will soon begin at Houston Methodist Hospital, delivered through funding from a collaboration with the Houston Texans and GE Healthcare. The project will take place at the hospital’s Concussion Center, and will make telemedicine available to student athletes at 19 rural school districts. Equipped with a Microsoft Surface, an athletic trainer will be available to go to a game or practice when a student athlete is pulled for a possible concussion. There, they will use the imPact neurocognitive assessment app and a Skype call with a Houston Methodist Concussion Center physician to perform a comprehensive concussion evaluation.
New York Presbyterian added a new capability to its suite of digital health tools with the integration of American Well into its NYP OnDemand app, offering patients video consultations via two clinic services called Digital Urgent Care and Virtual VisitNow. This is the latest feature in the NYP OnDemand service, which launched in July and has been gradually adding new features.
Some companies skirt the line of what is true telemedicine, but their very existence can still be contested. Opternative, a Chicago-based digital health company that offers an online refractive eye exam service that helps consumers get prescriptions for glasses or contacts, has teamed up with the Institute of Justice to sue the state of South Carolina, alleging that a new law restricting online eye exams is anticompetitive and unconstitutional.“We’re suing the state of South Carolina to protect patients’ right to accessible and affordable eye care services,” CEO and cofounder of Opternative Aaron Dallek said in a statement. “Doctors should be able to use Opternative’s innovative telehealth technology to help patients in South Carolina see clearly.”
Institutional grants going towards digital health
It’s not just VCs and angels pouring money into innovative healthcare projects. The National Institutes of Health expanded the $120 million grant it planned to give a consortium led by the Scripps Translational Science Institute. The award, which will be distributed over the next five years, has been expanded to $207 million, though the new funds also come with new responsibilities for the consortium as part of the White House's Precision Medicine Initiative.
The NIH also awarded the University of Massachusetts Amherst’s nursing school a $1.23 million grant to create a center dedicated to the development of technologies to help people manage fatigue and sleep impairment due to chronic illnesses.
The Scripps Whittier Diabetes Institute, part of Scripps Health in San Diego, secured a $2.9 million grant from the NIH to study text messaging in high-risk Hispanic populations in San Diego county. The study, called Dulce Digital-Me, will see participants using wireless devices to track their blood-sugar levels and medication adherence during a six-month study period.
The NIH also awared APDM, a 9-year-old Portland, Oregon company with a mission to "develop and commercialize best-in-class solutions for quantifying human movement with wearable technologies,” three grants worth a total of $4.7 million. They will work with the Oregon Health and Science University on all three projects, at least one of which is in preparation for a future commercial launch. The company makes a research-grade wearable called the Opal which can be worn in a variety of locations on the body. The device is designed to aid in gait and balance research toward the goal of fall prevention.
Another NIH-funded project will investigate a personalized web app that is specifically designed to encourage young men at-risk for HIV and other sexually transmitted infections to get routine testing.
The NIH is also funding the International Diabetes Closed Loop Trial: new clinical trial to investigate the use of artificial pancreas system that involves touchscreen insulin pump maker Tandem Diabetes Care; Dexcom, which makes continuous glucose monitor;, and digital, personalized medicine company TypeZero Technologies. The trial, which will take places at the University of Virginia, aims to enroll 240 adults with type 1 diabetes. The participants will come from 10 different clinical sites throughout the world – including Mount Sinai Hospital in New York, Stanford University Hospital and the Mayo Clinic in the United States, as well as medical centers in France, Italy and the Netherlands.
Other government moves
Accenture Federal Services has chosen Validic and Sutter Health to guide a pilot project exploring how patient-generated data can best be leveraged to improve research and healthcare. The goal is to capture information that Accenture can use to develop a research paper to inform government policy. The pilot is the next step in Accenture’s two-year consulting contract with the ONC to help the federal government create a framework for collecting and using patient generated health data in both research and clinical care, ultimately creating national standards.
National Coordinator Dr. Vindell Washington may have been dealt a relatively short stint in the role, but he’s set on doing as much as he can in the time he has to advance to ONC’s interests of data sharing and interoperability. Washington was on hand at the Connected Health Conference this week in National Harbor, Maryland to show off a demonstration of the FHIR (Fast Healthcare Interoperability Resources) protocol in action. In sessions with Epic, Allscripts, and Cerner, startups Medisafe, RxRevu, and CareEvolution all showed off their own FHIR-based apps that pulled data from EHRs to deliver an updating, de-duplicated medication list to a patient. The demonstrations were the culmination of a project begun at the HIMSS Annual Conference in February.