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Industry Insight

FDA Launches New Digital Tool to Help Capture Real-World Data From Patients

The FDA is announcing the MyStudies app, a new mobile technology to foster the collection of real-world evidence via patients’ mobile devices. Real-world data can be collected from a variety of sources, such as EHRs, claims and billing activities, and product and disease registries, as well as from patient-generated data including in home-use settings, or from data gathered from other sources, such as mobile devices.

As part of the agency’s work to foster greater opportunities around real-world evidence, the FDA partnered with Kaiser Permanente on a pilot study to measure the functionality and engagement of the MyStudies app. Based on the successful outcome of the study, the FDA is now releasing the open source code and technical documents that will allow researchers and developers to customize and use the FDA’s newly created MyStudies app to expand the diversity of health information available for clinical trials and studies, while directly capturing the perspective of patients. By providing the open source code, the agency is providing a tool that sponsors and developers can adapt to advance their specific clinical trial and real-world evidence needs, while also remaining compliant with the FDA’s regulations and guidance for data authenticity, integrity, and confidentiality.

For example, patients may be able to securely enroll in and contribute data to traditional clinical trials, pragmatic trials, observational studies, and registries. Sponsors may be able to customize their apps to administer questionnaires assessing patient-reported outcomes, symptom scales, or patient reports of prescription and over-the-counter medication use.

The overall effort was led by David Martin, MD, associate director for real-world evidence in the Office of Medical Policy in the FDA’s Center for Drug Evaluation and Research, with a grant from the US Department of Health and Human Services’ Patient Centered Outcomes Research Trust Fund. The open source code that serves as the foundation of the MyStudies app, as well as specifications for a secure patient data storage environment, were developed through a collaboration with Harvard Pilgrim Health Care Institute, LabKey, and Boston Technology Corporation.

“There are a lot of new ways that we can use real-world evidence to help inform regulatory decisions around medical products as the collection of this data gets more widespread and reliable. Better capture of real-world data, collected from a variety of sources, has the potential to make our new drug development process more efficient, improve safety, and help lower the cost of product development. If done right, it can also help make sure doctors and patients are better informed about the clinical use of new products, enabling them to make more effective, efficient medical choices. This will ultimately help us achieve better outcomes, and safer and more efficient use of expensive technology,” says FDA Commissioner Scott Gottlieb, MD. “Today we’re unveiling the new MyStudies app for the collection of real-world data. This digital platform enables developers to adapt our technology to advance new ways to access and use data collected directly from patients—with the necessary controls in place to ensure patient privacy. Our hope is that the collection of more real-world data directly from patients, using a secure app, will lead to more efficient product development and assist with safety monitoring.”

— Source: FDA


CommonWell Health Alliance Announces General Availability of Carequality Connection

CommonWell Health Alliance recently announced the rollout of its connection to the Carequality Framework, which is now generally available to CommonWell members and will increase HIT connectivity nationwide. Through some of the industry’s largest participating EHR vendors, the connection will allow CommonWell- and Carequality-enabled health care providers to connect and bilaterally exchange health data to improve care coordination and delivery.

“We are proud to break down yet another barrier to interoperability by making this much-anticipated connection available to our members and their clients,” says Jitin Asnaani, CommonWell Health Alliance executive director. “This increased connectivity will serve to empower providers with access to patient health data critical to their health care decision-making.”

Leveraging the technological infrastructure built by CommonWell service provider Change Healthcare, members Cerner and Greenway Health successfully completed a focused rollout of the connection with a handful of their provider clients, who have been exchanging data daily with Carequality-enabled providers. Since the connection went live in July, CommonWell-enabled providers have bilaterally exchanged more than 200,000 documents with Carequality-enabled providers locally and nationwide.

During the focused rollout, providers noted that this exchange increases ease of access to patient records from previous medical encounters and provides a foundation for helping to improve the delivery of patient care.

“The CommonWell-Carequality connection provides us the opportunity to directly access our patients’ records from the tertiary care centers in our region,” says Michael Donnenwerth, DPM, podiatry specialist at Winona Health, a Cerner client located in Winona, Minnesota. “We are now able to integrate new medications and problems into our EHR seamlessly, which provides the most accurate and up-to-date information possible. This flow of information has not only connected our medical records but it has allowed us to truly provide better care as the ambiguity of outside doctor visits has been virtually eliminated.”

“Thanks to the CommonWell-Carequality connection, our patients can have access to their medical records regardless of the EHR a health care facility uses,” says David Callecod, FACHE, president and CEO of Lafayette General Health, a Cerner client located in Lafayette, Louisiana. “When data is made readily available, providers can make diagnostic and treatment decisions more quickly, and patients can recover sooner. Better data means better communication with our patients and providers, better care, and better outcomes. This is a very powerful tool.”

This announcement marks a significant milestone on the path to achieving true nationwide HIT interoperability, advancing the vision of the Alliance to make health data available to individuals and providers regardless of where care occurs. Connecting some of the nation’s largest vendors, the CommonWell-Carequality connection will offer valuable patient insights to providers as they strive to deliver the best care possible to their patients.

“Now that we’re able to get patient information across disparate providers through the CommonWell-Carequality Connection, I think it will reduce hospital readmissions,” says Roneisha Ward, director of HIT at Carolina Family Health Centers, a Greenway Health client with locations throughout North Carolina. “By knowing what was done on the other end, we aren’t duplicating work in labs and referrals and patients don’t have to spend lots of time and money outside of the clinic. It’s a win-win for the patient, the organization, and the hospitals.”

With the connection officially in production, additional CommonWell members, including Brightree, Evident, and MEDITECH, are in the process of subscribing to the connection and taking it live with their provider clients.

— Source: CommonWell Health Alliance