Global Medical Technology Alliance (GMTA) papers on Cybersecurity, UDI and Use of Real World Evidence

Posted on 07.02.2018

The Global Medical Technology Alliance (GMTA) released three position papers in January 2018.

1. Medical Device Cybersecurity Principles

This document provides the medical device industry’s foundational principles for building a cybersecurity program for the development and deployment of secure medical devices.

1. Medical device development and security risk management throughout the entire (premarket and post-market) lifecycle of the device.
2. System-level security is a shared responsibility where all elements of the system must be appropriately managed and secured.
3. Coordinated disclosure that provides a pathway for researchers and others to submit information, including detected potential vulnerabilities, to the organization.
4. The development of consensus standards and regulations should be a collaborative effort between regulators, MD manufacturers, independent security experts, academia, and health care delivery organizations.

1. Unique Device Identification (UDI) – Insights and Benefits from a Single UDI System in the International Arena

A globally harmonized approach to UDI is critical to realizing the benefits of such a system, is a prerequisite for medical device traceability in a globalized economy, and lays the groundwork for the worldwide exchange of medical device data. A globally harmonized UDI system is achievable only when countries adopt similar UDI requirements.

The International Medical Device Regulators Forum is currently working on a global UDI application guide to provide guidance (definition, instruction, context, etc.) needed for a globally harmonized approach to the application of a UDI system.

1. Principles Regarding The Use of Real World Evidence

Medical device regulators have shown increased interest in the use of real world evidence (“RWE”) in pre- and post- market regulatory decision making. However, certain foundational principles are necessary with respect to the use of RWE, and to guide the governance and operation of a system that may be established to collect, disseminate and evaluate RWE.