Cybersecurity, respirator, broadband and personal protection top Feb's regulatory roundup

FDA issues draft cybersecurity recommendations

Biomedical // The Food and Drug Administration (FDA) recently issued draft guidance for medical device manufacturers on monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices after they enter the market. “All medical devices that use software and are connected to hospital and health care organizations’ networks have vulnerabilities — some we can proactively protect against, while others require vigilant monitoring and timely remediation,” says Suzanne Schwartz, M.D., acting director of emergency preparedness/operations and medical countermeasures in the FDA’s Center for Devices and Radiological Health. The agency is accepting comments on the draft guidance.

HHS to fund high-speed respirator manufacturing

Safety // Health & Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) will support the development of a high-speed manufacturing line to produce N95 respirators, which are used to prevent the transmission of microorganisms through airborne particles. The development of this line will take place under a 14-month, $1.6 million contract between ASPR and Halyard Health. U.S. manufacturing companies can produce up to about 150,000 respirators per day on a single machine. However, an analysis by the Institute of Medicine conducted in 2006 estimated that during a pandemic, at least 90 million filtering facepiece respirators would be needed in a 42-day period to treat influenza patients safely.

AHA recommends changes to rural broadband fund

Information technology // The American Hospital Association (AHA) recommended several changes to the Federal Communications Commission’s (FCC’s) Healthcare Connect Fund (HCF) to enhance participation and access to broadband for rural health care services. Specifically, AHA recommends that the FCC increase the HCF discount percentage from 65 to 85 percent; allow funding for consortium administrative expenses; streamline program administration; consider making remote patient monitoring an eligible expense; and reconsider using a more inclusive definition of the word rural. “Growth in the use of electronic health records, technology-based patient engagement strategies, telehealth and remote-monitoring technologies all require access to robust broadband connections,” notes Ashley Thompson, AHA senior vice president for public policy analysis and development, in comments submitted to the agency. “Further, the move to more coordinated care requires ever greater exchange of health information among providers.”