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Health Datapalooza Day 1: FDA’s Scott Gottlieb on Lowering Barriers to Digital Health Innovation

April 26, 2018
by David Raths
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FDA launches tech incubator called Information Exchange and Data Transformation
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Scott Gottlieb, commissioner of the U.S. Food and Drug Administration, kicked off the 2018 Health Datapalooza conference in Washington, D.C., on April 26 by announcing several new efforts at FDA to both streamline regulation of digital health tools and incorporate digital technology into the drug and device review processes.

In the first-ever presentation by an FDA commissioner to the Datapalooza conference, Gottlieb began by quoting Stanford University computer scientist Roy Amara, who said that we tend to overestimate the impact of a new technology in the short run, but we underestimate it in the long run. Although there has been a lot of hype around the promise of digital health, “the long run is now from where we sit at the FDA,” he said.

The FDA commissioner said the FDA is taking steps to make sure that beneficial technology can be made available much more quickly. “The FDA’s usual approach to regulation is not always well suited to digital health’s rapid pace of change,” he said. “The FDA must be as nimble as the technology we are asked to regulate.”

He then gave an update on the Software Precertification (Pre-Cert) Pilot Program, which was created last year to help inform the development of a regulatory model to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies. The FDA has been working on a pilot to create the building blocks of the program. Now, he said, it is making available a draft of the working model and a roadmap for how to develop it further. The next critical piece needed is input from software developers and the public. The program is expected to launch by the end of 2018, Gottlieb added, and be further refined in 2019.

Gottlieb said the FDA is opening a docket to create guidance concering how it would regulate software to be used with prescription drugs, building off the approach it has taken with medical devices. For instance, mobile devices could help confirm patients have taken medications or monitor side effects to classify pain or cognitive performance. All of that information could be incorporated into the EHR.

The FDA also is working to keep pace with the rapidly advancing field of artificial intelligence and machine learning, starting with medical imaging, Gottlieb said.

The agency also is starting to apply digital tools to update its own practices. A detailed examination of how it tracks submissions found a lot of inefficiencies from analog work flows, he said. Trial sponsors were submitting information via PDFs or paper. Medical offices at the FDA were mostly reviewing and track them individually. “Internal surveys found they spend 16 percent of time managing paper-based reports,” Gottlieb said, and a big portion of that time was spent on administrative file management tasks.” That makes it difficult for reviewers to focus on monitoring the safety of patients, and precludes analytics. “It is a fragmented workflow badly in need of change.” He said there have been successful pilots of digital submissions of data sets that can be visualized and analyzed in ways that can improve accuracy and efficiency.

Gottlieb also mentioned a new tech incubator at the FDA called Information Exchange and Data Transformation (INFORMED). It is a multidisciplinary initiative anchored in the FDA Oncology Center of Excellence designed to harness the power of big data and advanced analytics to improve disease outcomes.

He closed by noting that one of the biggest barriers to the advancement of digital health innovation is thecost and risk of new product development. “New digital tools can reduce these costs and break down artificial barriers,” Gottlieb said. We are rethinking our own mandate. Wee share your urgency and are committed to doing our part.”

 

 

 

 


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Geisinger, Merck Co-Develop Patient Communication and Care Delivery Applications

August 17, 2018
by Rajiv Leventhal
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Geisinger Health System and global biopharmaceutical company Merck have collaborated on two new mobile applications that will aim to help patient-provider communication and medication adherence.

According to officials in an announcement this week, the first of the two solutions, the Family Caregiver Application, helps two-way communications and coordination of care for patients and their caregivers. The other workflow solution, the MedTrue application, integrates different medication data sources to assist with medication reconciliation and adherence, resulting in a patient- and healthcare team-verified medication list. 

The applications, which were developed through an ongoing collaboration between Geisinger and Merck, are embedded directly within the electronic medical record (EMR) and in the healthcare provider's workflow. The applications are also accessible to patients and the Family Caregiver Application is accessible to family caregivers. Both workflow solutions can be used remotely.

What’s more, the applications will use SMART on FHIR (Substitutable Medical Applications, Reusable Technologies/Fast Healthcare Interoperability Resources) technology, an open, standards-based platform for utilizing data from disparate EMRs, so both products can be used in healthcare systems anywhere, officials said.

The Family Caregiver application was developed and piloted in oncology, and is designed to be translated to other therapeutic areas to enhance coordination of family caregiving activities among medical and caregiving teams. Meanwhile, officials noted, the driver behind the MedTrue application was the health system’s research which found that about 70 percent of its medication lists were inaccurate.

"Providing these tools for patients and family caregivers — tested within our own system — enables patients to be more active in healthcare decisions and could increase the likelihood that patients will adhere to their treatment plans and lead healthier lives,” said David H. Ledbetter, Ph.D., Geisinger executive vice president and chief scientific officer.

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Fitbit, Blue Cross Blue Shield Launch Mobile Health Partnership

August 13, 2018
by Heather Landi
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San Francisco-based fitness wearable maker Fitbit continues its push into the health plan market with a new digital health deal to incorporate its fitness tracker into health and wellness programs.

Blue Cross Blue Shield Association announced a partnership with Fitbit to include the company’s wearables and fitness trackers in its Blue365 health and wellness program for Blue Cross and Blue Shield (BCBS) members.

Through this program, more than 60 million BCBS members in 23 affiliated health plans to have access to a special offer on Fitbit activity trackers and smartwatches. The deal with BCBSA follows similar partnerships with Humana and UnitedHealthcare.

As part of a commitment to providing consumers with affordable health and wellness products, the Blue365 program also partners with employers to help build a culture of health in the workplace. Employers can either buy in bulk or subsidize a purchase of Fitbit devices for their employees.

“There is no question that increasing activity and moving more is a tremendous benefit that can improve health, and I'm excited Blue365 members will have even more incentives to get and remain healthy by exercising at a pace that's right for them,” Mark Talluto, vice president of strategy and analytics for Blue Cross Blue Shield Association (BCBSA), said in a statement. “This strategic partnership will bring personalized health and wellbeing to the next level, allowing members to put their health first.”

"Fitbit provides a powerful platform to engage consumers by offering data, insights and guidance to help them meet their health goals," Adam Pellegrini, general manager of Fitbit Health Solutions, said. "This partnership is an example of how Fitbit is expanding access to our devices and software so that we can help more people focus on their health and wellness and achieve better health outcomes."

Blue365 is available to members of the 23 participating BCBS companies, as well as the Blue Cross and Blue Shield Government-wide Service Benefit Plan, also known as the Federal Employee Program® (FEP®).

 

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Patient-Centered PHR Pulls Together Four Data Sources for Post-Market Surveillance of Medical Devices

August 12, 2018
by David Raths
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Can a patient-powered platform enable more robust and thorough post-market surveillance?

The Yale School of Medicine and Mayo Clinic are experimenting with a personal health record platform that allows patients to gather real-world data to share with researchers for post-market surveillance of medical devices.

Speaking to the NIH Collaboratory Aug. 10, Sanket Dhruva, M.D., an assistant professor of clinical medicine at the UCSF School of Medicine and a cardiologist at the San Francisco VA Medical Center, described some of the limitations of the current mechanisms used by the U.S. Food and Drug Administration for medical device surveillance and the potential for real-world evidence to help clinicians better understand the safety and effectiveness of devices.

Currently the FDA uses passive surveillance such as reporting of adverse events to the Manufacturer and User Facility Device Experience (MAUDE) database and does studies when safety concerns need to be investigated. Researchers at the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) are seeking to complement that approach with real world data. They are conducting a demonstration projects for NEST, the National Evaluation System for Health Technology, which was established by the Medical Device Innovation Consortium and funded by FDA.

Dhruva said the best data sources would be prospectively planned and offer continuously updated longitudinal follow-up for a comprehensive set of clinically relevant outcomes. “Ideally it would include patient-reported outcome measures as well as patient-generated data and would integrate seamlessly with existing data systems,” he said.  

Both claims and EHR data sources are commonly used for device surveillance. But they have limitations of their own, he said. Claims data are ubiquitous but not collected for supporting research. They are complete only if people remain in the same health system, so there tend to be gaps in data. Also they have time lags in availability. “They cannot identify use of a specific medical device,” Dhruva added.

EHR data offers very rich clinical information, but EHRs also are not designed to support research. The data is complete only if the patient remains in the same health system, so there may be many important gaps in data. “EHR data rarely includes patient-reported outcomes in a structured format,” Dhruva said. “Parts of patient-reported outcomes are in clinician notes or scanned documents,” he added. EHRs are rarely able to identify the use of a specific medical device.

In 2012, the FDA issued a rule requiring medical devices and packaging to have Unique Device Identifiers: However, there has been limited benefit because the UDI is unavailable in administrative claims data and EHR data, Dhruva said. “The UDI has a lot of potential to track devices and outcomes, but while we push for it to be better integrated in EHR and claims data, we can work on getting more real world data for medical device surveillance.”

The pilot project allows patients to provide their own outcomes (through short questionnaires and through synchronizing data from mobile health trackers) after they have received a procedure that utilizes medical devices. The Hugo personal health record aggregates data from four sources: EHRs, pharmacy portals, wearable devices  and patient answers to e-mailed questionnaires that become patient-reported outcomes.

(Hugo’s founder is Harlan Krumholz, M.D., a professor of medicine and epidemiology and public health at Yale School of Medicine.)

The study is following 60 patients for eight weeks after they undergo two procedures that use medical devices: the multiple devices (including sutures and stapler) used to perform bariatric surgeries (either sleeve gastrectomy or gastric bypass) in patients seeking weight loss and an ablation catheter when used in patients with atrial fibrillation seeking a return to sinus rhythm.

One goal is to test if the patients’ EHR data from multiple health systems can be synchronized into a research-ready database. (The Hugo PHR currently works with 600 health system portals. If patients have data with other providers’ portals, they can download Continuity of Care Documents and then upload them to Hugo, with research assistant help. Patients are being provided with syncable devices such as Fitbits to provide additional insights into their health and health outcomes. The study is also testing the feasibility of obtaining medication data from pharmacies. Patients who use Walgreen’s or CVS can log into their portals and download data.

Overall, the study is trying to answer the question of whether such a patient-powered  mHealth platform enable more robust and thorough post-marketing surveillance.

“Getting comprehensive longitudinal data “can only be obtained if the patients link and upload data from different health systems into the application,” Dhruva said. “We hope this is going to become easier through implementation of FHIR and Blue Button 2.0, but it is important that patients link or upload data from all the health systems from which they receive care.” He said combining that with patient-generated data should give clinicians a better understand of how they are doing in the post-procedure setting.

 

 


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