Yesterday, the FDA released draft guidance on the management of cybersecurity in medical devices submitted to the agency for premarket review. Noting that cybersecurity threats to the healthcare sector have increased in number and severity, the FDA offered new recommendations for device design, labeling, and documentation that medical device manufacturers will need to consider during premarket submission processes.

The guidance comes shortly after the FDA’s launch of its Medical Device Cybersecurity Playbook, which provides a framework for healthcare delivery organizations to use in preparing for and responding to cybersecurity threats against patient medical devices.

Given rapid changes in technology and increasing innovation in the digital health market, the guidance intends to decrease the risk of cyberattacks that could render medical devices inoperable and potentially harm patients. Comments on the draft guidance are due on March 18, 2019. Continue Reading FDA Issues New Guidance for the Management of Cybersecurity in Medical Devices

On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market.

The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request seeking $70 million to create a Center of Excellence on Digital Health that would, among other things, craft new regulations for third-party certification for developing medical devices. This comes as FDA is pushing guidance and innovative approaches for oversight of digital health (see our blog).

According to FDA Commissioner Scott Gottlieb’s announcement, the FDA’s plan organized into five points that seek to balance patients’ timely access to devices and safety and effectiveness. Continue Reading FDA’s Medical Device Safety Action Plan

The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation.

During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and outlined how the agency is committed to moving the ball forward in health care innovation through the following initiatives: Continue Reading FDA Advances Flexibility-Based Framework for Digital Health and AI

This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users—both healthcare professionals, and patients and caregivers. It also provides guidance on FDA’s interpretation of new software provisions in Section 3060 of the 21st Century Cures Act.

Given the explosion of these innovative digital health tools and their strong potential to transform healthcare, this guidance is a significant development for tech companies and investors focusing on this space. Comments will be accepted for 60 days. Continue Reading FDA Issues New Guidance for Clinical and Patient Decision Support Software

In a final guidance document released July 29th, the U.S. Food and Drug Administration (“FDA”) officially confirmed that it does not intend to review or require regulatory compliance for fitness trackers and certain health apps, collectively termed “general wellness products.”  This guidance, which is largely unchanged from the draft guidance issued in January 2015, coincides with FDA’s narrowing oversight of mobile medical apps and related tools.

According to the guidance, general wellness products are:

  1. Products that are intended for “general wellness use” (e.g., weight management, physical activity trackers, and stress management tools); and
  2. Products that present a low risk to the safety of users and others persons.

The primary distinction between a general wellness product and a medical device, which FDA does regulate, is that the intended use of a general wellness product is either to maintain or encourage a general state of health or healthy activity or to support a healthy lifestyle to help reduce the risk or impact of certain chronic conditions where there is a well-known connection. The guidance further explained that although general wellness products may claim to help manage or reduce the risk of certain chronic diseases, they may not claim to treat or diagnose a specific disease or condition.  Products that make these claims are considered medical devices and are subject to FDA regulation.

As mentioned above, this guidance is in line with FDA’s recent policy to exercise enforcement discretion when dealing with products that may help consumers manage or prevent ill health and pose a minimal risk of harm.  The policy attempts to strike a balance between ensuring consumer safety while supporting the rapid pace of innovation that is directed at consumer health.  This guidance along with earlier guidance can help mobile medical app, fitness trackers, wellness tools, and health information technology developers determine how to market their products in light of existing law and should be considered in the early stages of product development and business strategy.

For more information, please contact the authors of this post or your regular Crowell & Moring contact.

On May 11, the Departments of Health and Human Services (HHS), Labor (DOL) and Treasury (collectively, the “Departments”) issued Part XXVI of their FAQs about Affordable Care Act implementation. This latest FAQ provides additional guidance regarding “first-dollar” coverage of preventive services under the ACA (i.e., the requirement to provide certain preventive services without the imposition of cost sharing).

The FAQ focuses primarily on the coverage of Food and Drug Administration (FDA) approved contraceptives within the context of the ACA’s first-dollar preventive services mandate. The FAQ notes that the FDA has currently identified 18 different “methods” of contraception for women (including, among others, the patch, the sponge and three kinds of oral contraceptives). The FAQ then makes clear that plans and issuers must cover, without cost sharing, at least one form of contraception in each of these 18 “methods,” and that this coverage must include the clinical services, including patient education and counseling, needed for provision of the contraceptive method. For example, the FAQ states that a plan or issuer that covers, without cost sharing, some forms of oral contraceptives, some types of IUDs and some types of diaphragms, but excludes completely other forms of contraception, is not compliant with the ACA preventive services mandate.

Continue Reading DOL, HHS & Treasury Issue Guidance on Contraceptives and Other Preventive Services under ACA