FDA to Address Cybersecurity at Workshop

Cybersecurity continues to be a hot topic in healthcare with several areas of concern. These include the theft of personal health information from a provider’s database, using ransom wear to extract payment from providers without actually stealing information, and compromising the performance of medical devices that are connected to the network, employ wireless functions or are otherwise hackable in either real or imagined scenarios. One might note that these latter concerns may not be in proportion to the actual risk, ie they attract a great deal of attention and gnashing of teeth but in a rationale hierarchy of actual medical healthcare dangers they probably aren’t near the top. In this cybersecurity milieu the FDA has announced a 2-day workshop (May 18-19, 2017) to address it’s medical device mission of reasonable assurance of device safety and effectiveness, while not unduly interfering with timely innovation. In particular, the workshop is to address the “regulatory science” gaps that may prevent the FDA from fulfilling this mission. Regulatory science is the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated products. In addition, the FDA seeks to “encourage proactive development of analytical tools, processes, and best practices by the stakeholder community”. Thus there are two major issues. One is design and use practices to enhance cybersecurity, the seco...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Data Security Standards & Regulatory Source Type: blogs