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Apple to Introduce Health Records API

June 5, 2018
by Rajiv Leventhal
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Apple has announced that it will be introducing a Health Records API (application programming interface) for developers and researchers with the goal “to create an ecosystem of apps that use health record data to better manage medications, nutrition plans, diagnosed diseases and more.”

According to a June 4 announcement, the Health Records feature allows patients of more than 500 hospitals and clinics to access medical information from various institutions organized into one view on their iPhone. “For the first time, consumers will be able to share medical records from multiple hospitals with their favorite trusted apps, helping them improve their overall health,” Apple officials stated.

In January, Apple announced that it would be launching the Health Records feature that will allow consumers to see their medical records right on their iPhone. The tech giant began testing out the feature with 12 hospitals, noting at the time that it has “worked with the healthcare community to take a consumer-friendly approach, creating Health Records based on FHIR (Fast Healthcare Interoperability Resources), a standard for transferring electronic medical records.” Then, in March, Apple said that 39 health systems have already signed on to launch Health Records.

And now, with the new API set to be delivered starting this fall, officials say that developers building health apps can individualize experiences, with the user’s permission, based on the user’s unique health history across several key categories, including:

  • Medication tracking: Medisafe, a medication management app, will connect with the Health Records feature so consumers can import their prescription list without manual entry.
  • Disease management: A diabetes app could access a patient’s lab results from their Health Records as well as their diet and exercise details through the existing iOS HealthKit integration.
  • Nutrition planning: A healthy eating app could offer consumers tailored programs based on their high blood pressure or cholesterol results by serving up low salt or high fiber meal plans.
  • Medical research: With the new Health Records API, doctors can integrate patient medical data into their ResearchKit study apps for a more complete view of their participants’ health background.

Apple officials note that Health Records data is encrypted on iPhone and protected with the consumer’s iPhone passcode. When consumers choose to share their health record data with trusted apps, the data flows directly from HealthKit to the third-party app and is not sent to Apple’s servers.

“Medical information may be the most important personal information to a consumer, and offering access to Health Records was the first step in empowering them. Now, with the potential of Health Records information paired with HealthKit data, patients are on the path to receiving a holistic view of their health,” Jeff Williams, Apple’s chief operating officer, said in a statement. “With the Health Records API open to our incredible community of developers and researchers, consumers can personalize their health needs with the apps they use every day.”

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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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