Cyber incidents are on the rise with no signs of slowing down, particularly in the healthcare industry. To combat this trend, on September 27, 2023, the U.S. Food and Drug Administration (FDA) released guidance on cybersecurity in medical devices for quality system considerations and on premarket submissions. The guidance is intended to replace the FDA’s 2014
Long-Term Care Facilities Must Educate, Offer, and Report on COVID-19 Vaccinations for Residents and Staff, According to CMS Interim Rule
On May 11, 2021, the Centers for Medicare & Medicaid Services (CMS) of the U.S. Department of Health & Human Services published an interim final rule/guidance to establish COVID-19 vaccination requirements for Long-Term Care (LTC) facilities. The requirements are applicable to both residents and staff. LTC facilities have already been managing COVID-19 vaccination requirements both
FDA Names First Acting Director of Medical Device Cybersecurity
The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created 12-month post in which Fu will “work to bridge the gap between medicine and computer science and help manufacturers protect
CDC Expands Guidance on Workplace SARS-CoV-2 Testing to Require Informed Consent
As employers continue to grapple with a safe return to the workplace, on January 21, the U.S. Center for Disease Control and Prevention (CDC) issued new guidance for businesses and employers on SARS-CoV-2 testing of employees, as part of a more comprehensive approach to reducing transmission of the virus in non-healthcare workplaces. While the CDC
More EEOC COVID-19 Guidance: Testing, Screening, Managers, Confidentiality, and Telework
Since March of this year, the Equal Employment Opportunity Commission (EEOC) has released guidance on a near-monthly basis addressing various FAQs concerning COVID-19 issues. The guidance has focused on disability-related inquiries, confidentiality, hiring, and reasonable accommodations under the Americans with Disabilities Act (ADA), as well as issues under Title VII of the Civil Rights Act
FDA Focuses Attention on Medical Device Cybersecurity Risks
All companies in this day and age must devote some attention to cybersecurity risks. Regardless of industry, almost every entity maintains some form of personally identifiable information that requires protection (e.g., credit card information, Social Security numbers, bank account information, etc.). However, the medical device industry has additional concerns – it must make sure that
Health Apps: Convenience vs. Security Risks
The pace of innovation in healthcare today has produced an amazing increase in the number of available mobile apps for health-related information. More than 300,000 healthcare apps are available online. These apps are developed and designed to fit within the “connected health model” which attempts to provide flexible and efficient healthcare services by using connected
FDA Issues Draft Guidance for Connected Medical Devices
Demonstrating a continued focus on information security, the Food and Drug Administration (FDA) published draft guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. As the title indicates, the draft guidance focuses on issues manufacturers should address in the development and design of medical devices prior to sale to consumers. This
FDA Issues Draft Cybersecurity Guidance for Device Manufacturers
Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have
Social Media Guidance Issued For Pharmaceutical Entities
The U.S. Department of Health and Human Services, Food and Drug Administration (FDA) recently issued draft guidance entitled “Guidance for Industry-Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media For Prescription Human and Animal Drugs and Biologics.”
The draft guidance is intended to describe the FDA’s current thinking about how manufacturers, packers, and distributors