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By Marc Sebes, VP of Product Management In-home clinical devices are among a number of digital health technologies that are being used to streamline clinical trial processes and enable pharmaceutical companies and contract research organizations (CROs) to monitor participants remotely. As partially or fully remote clinical trials gain market momentum, these particularly impactful devices enable the remotely collected participant data to be integrated into a clinical trial system, patient community application or engagement platform. Researchers and clinicians are then provided with access to real-time participant data at a reduced collection cost. Clinical devices are instruments, implements or machines intended for use in the diagnosis of disease or monitoring of conditions. Examples of commonly used in-home clinical devices include blood pressure cuffs, blood glucose meters, sleep tracking devices, spirometers and weight scales. Three factors have led to the increased usage of these devices in clinical trials. First, the escalating competition caused by new entrants providing in-home clinical devices has led to better usability and accuracy from all vendors. Second, as evidenced by the specialized digital health displays in retail stores like Target, consumer demand and adoption of in-home monitors is growing. Third, as data from these devices has become more accessible for clinicians, the value of utilizing these devices in trials has increased. Delving further into the increased value of real-time connectivity, the previous lack of device connectivity in the market placed a substantial burden on trial participants and researchers required to routinely collect data. Previously, patients were required to either manually record the readouts or take the device to a trial site for the data to be downloaded by a clinician. This made conducting effective remote clinical trials nearly impossible; mandating participants to self-report data multiple times a day is not only an inefficient means for data acquisition, but it also greatly heightens the risk of incomplete and inaccurate data being provided to researchers. Today, however, devices are becoming increasingly connected via Bluetooth Smart technology or application program interfaces (APIs). This growing device connectivity is enabling data to pass wirelessly in real-time from a blood pressure cuff, for example, to a smartphone and into the clinical trial’s platform or system. Unfortunately, some widely-used legacy devices remain unconnected. To bridge the gap, new data capture technologies have been developed to quickly digitize biometric readings from non-connected devices. Validic’s VitalSnap, which leverages optical character recognition (OCR) software, enables participants to capture health data via their smartphone’s camera from non-connected medical devices and automatically transfer it to a clinician. This provides researchers with the ability to access data from devices that are already clinically validated and being used in the trial.   As clinical devices continue to mature and are integrated into the connected health ecosystem, they will become an increasingly vital component for creating better results for both clinical trial participants and sponsors. Regulators expect clinical devices that generate these data to meet certain standards, therefore most are FDA-approved Class II devices that follow the 510(k) pathway. And, the data generated by these devices are generally accepted in clinical trials. In-home clinical devices are already benefiting and supporting trials today. As data is delivered in more real-time, there is less need for participants to spend time at sites. Additionally, in-home devices allow for more frequent empirical data to be collected throughout the trial. Utilizing the increased number of readings, additional correlations can be drawn from patient-reported outcomes, resulting in less uncertainty and more confident results. In summary, connected in-home clinical devices are allowing for more passive data collection that enables participants to have a more active and engaged role in clinical trials, leading to better results at a lower cost.

Half of hospitals routinely use patient information received electronically from other providers, which National Coordinator Karen DeSalvo, MD said is an indication of how far the healthcare industry has come for both patients and clinicians.

Mayo Clinic will provide the infrastructure to store, analyze and host data for researchers as part of a program that aims to enroll one million people to boost President Obama’s Precision Medicine Initiative.

Simplified regulations around MACRA meaningful use could address the loss of efficiency and usefulness of electronic health records software to enable more flexibility for the doctors using them, said Shawn Griffin, MD, of Memorial Hermann Physician Network.

Chipmaker said that Lumiata will use the money to drive predictive analytics to improve risk and care management for organizations practicing population health. 

With meaningful use winding down, Poulton urged other EHR makers to work on technologies that enable providers to be more effective in the changing world or healthcare. 

The new organization will operate under parent company Ascension and sweeping leadership and structural changes will accompany the consolidation. 

While EHR implementations can be disruptive, the hospital system implemented new clinical and revenue cycle software in January and is pointing to its strategy of engaging every employee in the electronic health records system deployment.

New research published in the Journal of the American Medical Association found mostly positive feedback from both doctors and patients, though there are still some clinicians who prefer to keep their notes from patients.  

Financial incentives, information technology advances and new care models have created fertile soil for population health management programs to grow. But for these efforts to flourish healthcare organizations need more sophisticated analytics, patient stratification, community involvement and care management, according to a May 2016 report from PwC Health Research Institute. “So far, most efforts have been narrow, with promising results. These early results signal the full potential of population health if scaled across geographies, diseases and the continuum of care,” PwC’s “Population Health: Scaling Up,” report noted. “Yet many organizations still struggle to scale their efforts – an essential step as they take on more risk in value-based payment contracts.” [Also: The essence of population health: Design and user experience] Seventy percent of clinicians do not participate in risk-based, incentive-based or shared-savings reimbursement models, PwC said, even though adoption of these payment models is a major goal of the Centers for Medicare and Medicaid Services. Healthcare organizations with evidence that population health programs are working well on a large scale are more likely to be rewarded under these reimbursement models. The PwC report suggested six steps healthcare organizations can take to advance population health programs to highly effective levels. First, healthcare organizations should “pick a major,” PwC said. So, for instance, carrying on the university area of study example, an academic medical center might “minor” in population-based care at the community level and “major” in acute and chronic health population health. Second, healthcare organizations need to “think retail,” the report continued. “Today’s consumers are expecting health providers to offer the personalized levels of service and convenience they receive from other industries,” PwC said. More than 80 percent of consumers are open to non-traditional ways of receiving care, PwC added, such as virtual visits, at-home diagnostic monitoring and home care visits. Establishing a funding mechanism is a third step healthcare organizations must take to achieve success in population health management, PwC advised. “Organizations should design a payer strategy for population health to manage risk and sustain operations,” the report said. “Some providers are partnering with insurers to outsource activities such as risk score optimization, actuarial analysis and claims administration. Others are on their way to becoming licensed health plans, a growing trend in a value-based health economy.” Healthcare organizations also should plan for early losses and contract accordingly, the PwC report suggested as a fourth step. “Organizations should evaluate their abilities to tolerate risk and assess their capital positions to support population health strategies,” the report said. “Organizations should structure partnership contracts so that risk is shared appropriately among all partners in their population health delivery networks.”  [Also: Healthcare analytics has long journey to deliver real value, data scientist says] Fifth, healthcare organizations should be prepared to redirect pent-up demand. “Organizations with excess demand may have smoother transitions as they operate more efficiently,” PwC said. “They can replace lost volume, continue to operate at high capacity and improve their returns on fixed costs.” Finally, to succeed in population health, providers must evaluate programs often and make adjustments promptly, the PwC report advised “Population health programs require heavy operations investments and have high fixed costs,” the report said. “Organizations should build care services around patient cohorts and actively monitor health outcomes. They should regularly reevaluate whether patients assigned to each group still belong there.” Twitter: @SiwickiHealthIT Email the writer: bill.siwicki@himssmedia.com Like Healthcare IT News on Facebook and LinkedIn