Following through on Republican campaign promises, two key Congressional committees released legislation yesterday that further the process of repealing and replacing the Affordable Care Act (ACA). After more than 60 attempts to repeal the ACA since 2010, GOP members of the House Energy and Commerce and Ways and Means Committees released details of the “American Health Care Act” (AHCA). Reaction to the AHCA has been swift and sharp portending a long road from producing legislation that can reach the President’s desk. Continue reading
Category Archives: Medical Devices
All is Well: FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016
The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness: Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout. While not much has changed from the 2015 draft guidance, the number of mobile apps and general wellness products that are pushing the limits of what the FDA believes could be “devices” under the Food, Drug, and Cosmetic Act (FDCA) increases daily.
In order to fit under the FDA Policy, the product needs to both solely marketed for general wellness and present a low risk of safety to the user and other persons. The guidance provides useful examples that anticipate the desire to help “reduce the risk of” or “live well with” chronic conditions, the most interesting boundaries of the Policy for those wishing to differentiate themselves within the wellness industry.
Agency metrics on the 513(g) Requests for Information may provide some feedback on the impact of the Policy since its draft issuance, and future enforcement needs to be monitored for defining the limits of the Policy.
Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of Privacy Professionals (IAPP) conference in Washington, DC. The Guidance is a tool created in collaboration with the FTC, the U.S. Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) to assist app developers in determining what laws and regulations apply to their products. Continue reading
Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in their medical devices. From the letter, the rationale for selecting these companies is that together they “control more than one-quarter of the global medical device market” and it is her hope that they can send “a signal” to the broader medical device industry. Continue reading
Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers should monitor and address cybersecurity risks. The Guidance is the latest manifestation of a federal agency weighing in on the continually growing concern caused by cybersecurity threats. Suzanne Schwartz of the FDA’s Center for Devices and Radiological Health commented that the Guidance “will build on the FDA’s existing efforts to safeguard patients from cyber threats by recommending medical device manufacturers continue to monitor and address cybersecurity issues while their product is on the market.”
Tuesday, Senator Lamar Alexander (R-Tenn.), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced that he will pursue a “step by step” approach to crafting major biomedical innovation legislation. This is a marked departure from both the House-passed 21st Century Cures bill and the previously announced Senate plan. Continue reading
On Monday, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released an online platform designed for use by developers of mobile medical applications (apps). The site allows users to submit questions regarding compliance with the Health Insurance Portability and Accountability Act (HIPAA) and to access basic HIPAA resources. HIPAA compliance by mobile medical apps has been an area of significant confusion. The intent of the site is to provide these developers, often small start-ups, with a low cost and easy way to become familiar with HIPAA. Continue reading