FDA Launches Precertification Pilot Program for Digital Health Technologies | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

FDA Launches Precertification Pilot Program for Digital Health Technologies

July 28, 2017
by Heather Landi
| Reprints
Click To View Gallery

As announced in June, the U.S. Food and Drug Administration (FDA) is moving forward on a broad initiative focused on fostering new innovation in digital health, and one major part of this initiative will be a Digital Health Innovation Action Plan outlining how devices will be regulated.

On Thursday, the agency released its Digital Health Innovation Action Plan, as well as unveiled a new precertification pilot program that would soften the regulatory requirements for digital health companies with a track record of developing and testing quality products.

The purpose of FDA’s Software Pre-Cert pilot is to leverage customer input to develop a program that can help reduce the time and cost of market entry for software developers that FDA determines reliably manufacture high-quality, safe and effective digital health devices while providing appropriate patient safeguards, the agency said. Applying such an approach could improve support for continued innovation, allow for more rapid availability of new and updated software, and better focus FDA resources on higher-risk developers and products.

The FDA designed the new digital health pilot program to include up to nine software firms of various sizes. Initial participants in the pilot program will range from small startups to large companies that develop both high- and low-risk software products that are devices, the agency said.

Beginning August 1, the FDA will start evaluating applications to fill the pilot program’s nine slots. Companies interested in participating in the pilot can submit a statement of interest to FDAPre-CertPilot@fda.hhs.gov.

The FDA will hold a public workshop in January 2018 to report on and review its initial findings. The Federal Register notice announcing the Software Pre-Cert Pilot Program with more details about participation and the FDA’s goals can be found here.

In a blog post about the pilot program, FDA Commissioner Scott Gottlieb, M.D., wrote that digital health product developers will be selected for the program based on the following:

  • The company must be in the process of developing or planning to develop a software product that meets the definition of a medical device;
  • The company must have an existing track record in developing, testing, and maintaining software products and demonstrating a culture of quality and organizational excellence measures that are tracked by Key Performance Indicators (KPI) or other similar measures;

And during participation of the pilot, companies must agree to:

  • Provide access to measures for developing, testing and maintaining software products and demonstrating a culture of quality and organizational excellence measures by KPI;
  • Collect real-world post-market data and provide it to FDA;
  • Meet with FDA for real-time consultation;
  • Be available for site visits from FDA officials; and,
  • Provide information about the firm’s quality management system.

 

In the blog post, Gottlieb wrote that the FDA has been challenged with determining how to best regulate non-traditional medical tools with the traditional approach to medical product review. “We envision and seek to develop through the Pre-Cert for Software Pilot a new and pragmatic approach to digital health technology. Our method must recognize the unique characteristics of digital health products and the marketplace for these tools, so we can continue to promote innovation of high-quality, safe, and effective digital health devices,” Gottlieb wrote.

“FDA’s traditional approach to medical devices is not well suited to these products. We need to make sure our approach to innovative products with continual updates and upgrades is efficient and that it fosters, not impedes, innovation,” he wrote. “We need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”

To this end, the FDA’s new, voluntary pilot program is a step toward developing a tailored approach by “looking first at the software developer or digital health technology developer, rather than primarily at the product,” Gottlieb wrote.

The FDA aims to develop a precertification program that could replace the need for a premarket submission for certain products and allow for decreased submission content and/or faster review of the marketing submission for other products. Under this approach, the FDA’s Center for Devices and Radiological Health (CDRH) could ‘pre-certify’ eligible digital health developers who demonstrate a culture of quality and organizational excellence based on objective criteria. Pre-certified developers could then qualify to be able to market their lower-risk devices without additional FDA review or with a more streamlined premarket review, the agency said.

“The goal of our new approach is for FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets the necessary quality standards and pre-certify the company. Pre-certified companies could submit less information to us than is currently required before marketing a new digital health tool,” Gottlieb wrote. “In some cases, pre-certified companies could not submit a premarket submission at all. In those cases, the pre-certified company could launch a new product and immediately begin post-market data collection. Pre-certified digital health companies could take advantage of this approach for certain lower-risk devices by demonstrating that the underlying software and internal processes are sufficiently reliable. The post-market data could help FDA assure that the new product remains safe and effective as well as supports new uses.”

At the same time that it announced the pilot, FDA’s Center for Devices and Radiological Health (CDRH) also published its Digital Health Innovation Action Plan to provide details and timelines for its integrated approach to digital health technology and the implementation of the 21st Century Cures Act.

The Health IT Summits gather 250+ healthcare leaders in cities across the U.S. to present important new insights, collaborate on ideas, and to have a little fun - Find a Summit Near You!


/news-item/mobile/fda-launches-precertification-pilot-program-digital-health-technologies
/news-item/mobile/labcorp-joins-apple-health-records-project

LabCorp Joins Apple Health Records Project

November 5, 2018
by Rajiv Leventhal, Managing Editor
| Reprints

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.

More From Healthcare Informatics

/news-item/mobile/himss-analytics-introduces-infrastructure-adoption-model-health-systems

HIMSS Analytics Introduces Infrastructure Adoption Model for Health Systems

October 25, 2018
by Rajiv Leventhal, Managing Editor
| Reprints

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.”

Related Insights For: Mobile

/webinar/clinical-team-communication-and-data-access-palm-your-hand

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.

See more on Mobile

betebet sohbet hattı betebet bahis siteleringsbahis