Home / Tag Archives: FDA

Tag Archives: FDA

FDA Issues Warning on Potential Insulin Pump Hack

The Food and Drug Administration warned that insulin pumps manufactured by Medtronic in 2012 may bring potential cybersecurity and health risks to patients, Nextgov reported Friday. According to a separate statement, other users may access a nearby MiniMed insulin pump wirelessly and manipulate its settings to cease or over-deliver insulin to patients.

Read More »

DARPA Seeks to Develop Genetics-Based Med Tech

The Defense Advanced Research Projects Agency has launched a four-year effort to develop new genetics-based applications addressing two public health issues. DARPA said Thursday that its Preemptive Expression of Protective Alleles and Response Elements or PREPARE program aims to control protective genes for defense against influenza and ionizing radiation. 

Read More »

Scott Gottlieb: FDA Eyes Regulatory Framework for AI-Based Medical Devices

Scott Gottlieb, commissioner of the Food and Drug Administration, announced the release of a discussion paper as the agency considers developing new regulatory framework to advance the development of artificial intelligence-based medical devices. “We are exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software as a medical device is maintained,” Gottlieb said in a statement published Tuesday

Read More »

DHS Helping FDA Cyber Secure Medical Devices

The Department of Homeland Security is working with the U.S. Food and Drug Administration to protect connected medical devices from emerging cyber threats, Federal News Network reported Thursday. In October, DHS began using the medical device security playbook the FDA issued to guide the government and industry in protecting such technologies.

Read More »

FDA Issues Draft Guidance for Medical Device Cyber Management

The Food and Drug Administration has released a draft guidance to provide recommendations that seek to help companies address cyber risks in medical devices prior to the submission of premarket applications for their products. FDA said Thursday the recommendations in the guidance document aim to facilitate the review process for premarket submissions and reduce the risk of patient harm associated with devices with cyber vulnerabilities.

Read More »

Researchers Call Out HHS for Lack of Standardized Data Sharing Protocols

Researchers from the Department of Health and Human Services' Office of the Chief Technology Officer have learned that HHS constituent agencies do not have a standardized mechanism for sharing restricted and nonpublic data. The researchers said in a September 2018 report that there is no uniform documentary requirement among HHS agencies for data requests, and, in many agencies, there is a lack of a "data governance group" that tracks requests and their outcomes. Such deficiencies result in procedural inefficiencies and the siloing of information.

Read More »