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.
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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:
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On October 28, 2015, the U.S. Copyright Office of the Library of Congress (the “Office”) issued a Final Rule containing several exemptions to the Digital Millennium Copyright Act that expanded access to medical device computer programs and the patient data they generate.  The Digital Millennium Copyright Act allows intellectual property holders to install “technological protection measures” (TPMs) in their software which blocks unauthorized inspection of data to protect copyright.  Under the Act, the Library of Congress grants exemptions to TPMs every three years.

In the Final Rule, the Office included an exemption for researchers investigating computer programs on devices and machines for good faith security research. The Office found that legitimate security research has been hindered by TPMs that limit access.  Covered devices include medical devices used for patient implantation or corresponding personal monitoring systems, as long as they are not used by patients or for patient care.  The research exemption begins 12 months after the regulation’s effective date, meaning it starts on October 28, 2016.  Additionally, the Office created an exemption for patients who seek to passively access information that is already being generated by their own medical devices or personal monitoring systems.  Unlike the research exemption, the patient monitoring exemption takes effect immediately, and it is limited to patients themselves, as opposed to researchers or other parties.


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