Protecting Independent Medical Device Research

Via Cyberlaw Clinic

Over the past several months the Cyberlaw Clinic has been working with medical device researchers Hugo Campos, Jay Radcliffe, Karen Sandler, and Ben West, in a proceeding before the Copyright Office regarding the anticircumvention laws created in the Digital Millennium Copyright Act. Here’s what we’ve been doing, and why we’re doing it.

The Clinic has written about this proceeding twice before, but as a quick review: our clients each study the safety, security, and effectiveness of medical devices. Some look at the devices from a system design perspective, analyzing the hardware and software of the devices for misconfigurations or vulnerabilities. Others look at the devices as they are applied to a particular patient’s care, and help patients retrieve important information off the devices that the device otherwise would not share, or would only make available through periodic checkups with doctors once every several months. Their research has helped patients and doctors better tailor care, the public understand the nature of medical device risks, and regulatory agencies like FDA improve government oversight of devices.

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