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Apple, Fitbit Chosen for FDA Pilot to Accelerate Digital Health Tech Approval

September 27, 2017
by Heather Landi
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Technology companies Apple, Fitbit, Samsung and Verily were among nine companies that the U.S. Food and Drug Administration (FDA) selected for a pilot program that will test a new digital health software pre certification process (FDA Pre-cert).
 
The FDA’s Pre-cert pilot program is intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product, according to a FDA press release. “The goal of this new approach is for the FDA to, after reviewing the systems for software design, validation and maintenance, determine whether the company meets quality standards and, if so, to pre-certify the company,” the FDA stated.
 
With information gained from the pilot program, the FDA hopes to determine the key metrics  and performance indicators for recertification and identify ways that pre certified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program, the FDA stated. “The FDA is also considering, as part of the pilot program, whether and how, pre certified companies may not have to submit a product for remarked review in some case,” the FDA stated in the press release.
 
While there are some big names in the technology world on the list of the pilot participants—Apple, Fitbit, Samsung—there are also some small startups as well. The participants in the pilot are: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily. Pear Therapeutics is a startup that developed a mobile app designed to help treat substance use disorder, and the app was recently approved by the FDA. Tidepool developed an open source platform for diabetes data.
 
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” FDA Commissioner Scott Gottlieb, M.D., said in a statement.. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.”
 
In accounting the participating companies, the FDA noted that the participants represent a wide range of companies and technology in the digital health sector, including high- and low-risk medical device software products, medical product manufacturers and software developers. The FDA says more than 100 companies expressed interest in the pilot program. In selecting the participants, the FDA says it considered several factors, including company size, demonstrated record of quality and organizational excellence, clinical focus area and the risk profile of the product.
 
The FDA launched the Pre-cert pilot program back in July as part of the agency’s Digital Health Innovation Action Plan, which outlines the agency’s vision for fostering digital health innovative while continuing to protect and promote public health by providing clarity on medical software provisions of federal legislation passed in 2016 (21st Century Cures Act).
 
As part of the Pre-cert pilot program, participants have agreed to provide access to measures they currently use to develop, test and maintain their software products, including ways they collect post-market data. Participants also agreed to be available for site visits from FDA staff, and provide information about their quality management system. This sharing will help the FDA continue to build its expertise in these areas, while giving the agency the information it needs to provide proper oversight of these products and firms.
 
The FDA plans to share public updates about the Pre-cert pilot program via the pilot program webpage as well as through stakeholder meetings, including a January 2018 workshop. Throughout the pilot, the FDA will solicit feedback from the selected participants, as well as from industry, stakeholder groups and the public.
 
 

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LabCorp Joins Apple Health Records Project

November 5, 2018
by Rajiv Leventhal, Managing Editor
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LabCorp, a provider of clinical laboratory and end-to-end drug development services, has announced that it has enabled Apple’s Health Records feature for its patients.

This iPhone feature aims to make it easier for LabCorp patients to access their LabCorp laboratory test results, along with other available medical data from multiple providers, whenever they choose, according to officials.

In January, Apple announced that it would be testing the Health Records feature out with 12 hospitals, inclusive of some of the most prominent healthcare institutions in the U.S. Since that time, more than 100 new organizations have joined the project,  according to Apple.

LabCorp test results are viewable in the Apple Health app for LabCorp patients who have an account with the company, and enable integration with the Health Records app. In addition to their LabCorp test results, patients will have information from participating healthcare institutions organized into one view, covering allergies, medical conditions, immunizations, lab results, medications, procedures and vitals.

Patients will receive notifications when their data is updated, and the Health Records data is encrypted and protected with the user’s iPhone passcode, Touch ID or Face ID, according to officials.

“LabCorp on Health Records will help provide healthcare consumers with a more holistic view of their health. Laboratory test results are central to medical decision making, and broadening access to this information will help patients take charge of their health and wellness, and lead to more informed dialogues between patients and their healthcare providers,” David P. King, chairman and CEO of LabCorp, said in a statement.

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HIMSS Analytics Introduces Infrastructure Adoption Model for Health Systems

October 25, 2018
by Rajiv Leventhal, Managing Editor
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HIMSS Analytics, the research arm of the Healthcare Information and Management Systems Society, announced the introduction of the Infrastructure Adoption Model, or INFRAM, which is designed to measure the technical infrastructure used within a health system.

The INFRAM focuses on five technical subdomains, allowing organizations to benchmark how their infrastructure operates within the following areas: mobility; security; collaboration; transport; and data center.

Similar to HIMSS Analytics’ well-known Electronic Medical Record Adoption Model, or, EMRAM, the INFRAM is an eight-stage model (0 – 7) that allows healthcare IT leaders to map the technology infrastructure capabilities required to reach their facility’s clinical and operational goals, while meeting industry benchmarks and standards.  The final stage, Stage 7, guides organizations towards optimized information integration, contextualization and orchestration essential for the delivery of higher order local and virtualized care processes.

For reference purposes, Stage 0 on the model represents that an organization does not have a VPN, intrusion detection/prevention, security policy, data center or compute architecture. Stage 3 signifies that an organization has an advanced intrusion prevention system, while Stage 5 represents having video on mobile devices, location-based messaging, firewall with advanced malware protection, and real-time scanning of email hyperlinks.

HIMSS officials note that by identifying specific benchmarks for organizations to reach before they go live with EMR, systems, the INFRAM aims to ensure that a health system’s infrastructure is stable, manageable and extensible. Through this, organizations can ideally improve care delivery and create a pathway for infrastructure development tied to business and clinical outcomes.

 “The INFRAM is a welcome addition to our maturity model suite and addresses a longstanding need – guiding healthcare organizations in securely implementing the infrastructure with which their EMRs are built upon,” Blain Newton, executive vice president, HIMSS Analytics, said in a statement. “We have seen health systems engage with advanced clinical applications, only for them to ‘glitch’ under infrastructure that isn't powerful enough to support their tools. With the INFRAM, healthcare providers can develop a detailed, strategic technology plan that defines their organization's current state, desired future state, and each stage in between to achieve their clinical and operational goals.”

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Clinical Team Communication and Data Access in the Palm of Your Hand

Thursday, October 25, 2018 | 1:00 p.m. ET, 12:00 p.m. CT

Eisenhower Health, a west coast-based Magnet Hospital, implemented an enterprise-wide solution enabling mobile communications and collaboration across all care teams, linking the entire enterprise, advancing its communications capabilities, creating access to an enterprise directory, and improving care team response and turnaround times.

Additionally, the system provided extensive and comprehensive reporting with data analytics showing where and to what extent response improvements were made, but also providing the information the hospital needed to better utilize the system and make adjustments to improve results.

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