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Unleashing the Power of Flexible TPLC Evaluations

Updated: Jan 5, 2018

EP3 Foundation Presents at

Unleashing the Power of Flexible TPLC Evaluation

The Medical Epidemiology Device Network hosted their annual conference Oct 19th and 20th at FDA Headquarters.

Dr. Jack Lewin, Chair of the National Coalition on Healthcare and Board Chair of the EP3 Foundation presented Unleashing the Power of Flexible TPLC Evaluation.

Dr, Lewin and Jonathan Hare, CEO of Webshield and Trustee of EP3 shared innovative ways to collaborate and leverage existing resources, improve and enhance evaluations while eliminating current gaps and fragmentations of efforts, data, and information.

To protect and promote public health, MDEpiNet collects, tests and shares Total Product Life Cycle data (TPLC) and information about medical devices. The intention of TPLC is to provide data to manufacturers enabling them to be proactive and address quality related issues as early as possible. To that end, MDEpiNet medical device community has identified many unmet needs. Evaluations and processes must be able to adjust, evolve and mature over time if they are going to improve patient safety while enhancing innovation.

The Total Product Life Cycle (TPLC) database integrates pre-market and post-market data about medical devices. It includes information pulled from CDRH databases, including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. EP3 Medical Device Networks improve the capacity of individuals, institutions, and manufacturers to develop and apply new methodological techniques and synthesis of knowledge about device evaluation processes.

Our networks enable participants to share data at the smallest possible unit across many networks. This technology allows small, hard to find, obfuscated bits of information to be shared via multiple networks based on the relevant laws, policies, and consent. This directly addresses the biggest obstacles to providing patient-driven, integrated care.

We enable all participating providers and manufacturers to share and communicate with each other with fine granular access and approvals. EP3 Foundation Device Networks enhance TPLC Evaluations and facilitate innovation.

  • Share data and communicate with each other when allowed

  • Link personal data from different sources at a granular level

  • Verify identity using various attributes from multiple networks

  • Automatically ensure policy compliance at the attribute level

  • Obfuscate information beyond encryption to maintain secure yet computable for research, public health and improve health outcomes.

Sharon-Lise T. Normand, Ph.D., a professor of health care policy (biostatistics) in the Department of Health Care Policy at Harvard Medical School and the Department of Biostatistics at the Harvard School of Public Health, moderated the discussion.

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