The Cyberlaw Clinic represented a coalition of medical device researchers in the sixth triennial rulemaking by the Library of Congress and Copyright Office for exceptions to the copyright anticircumvention rule, 17 U.S.C. § 1201(a)(1)(A). As set forth in detail in the filings, the coalition sought an exemption for those access the source code and data outputs of devices, in order to conduct research into the safety, security, and effectiveness of the devices. This was designed in the rulemaking as the “Class 27: Software – Networked Medical Devices” exemption.
The work on this exemption spanned several semesters, and included:
- An initial petition for an exemption, filed in November 2014, in response to a notice of inquiry by the Copyright Office. More about this initial filing can be found here.
- An initial comment, filed in February 2015, that more fully explained the exemption sought and defended its qualifications under standards set forth in the Copyright Office’s notice of proposed rulemaking. More about this filing can be found here. Additional comments in support of this class were filed by Jay Freeman, Matthew Green, Public Knowledge, the Free Software Foundation, and 1659 individuals through the Digital Right to Repair website.
- A reply comment, filed in May 2015, in response to opposition comments filed by Advanced Medical Technology Association (“AdvaMed”), the Intellectual Property Owners Association, the National Association of Manufacturers, LifeScience Alley, and Jay Schulman in March 2015. Other reply comments in support of the class were filed by New America’s Open Technology Institute, Public Knowledge, Bruce Schneier, Jay Freeman, Gregory Borodiansky, Henry Feldman, Patrick Ferguson, Don Lowery, and Jason Weingartner.
- A letter to the Copyright Office, filed in June 2015, in response to specific questions presented by the Office following a hearing about the class in late May. The transcript of the hearing can be found here, and additional information about the hearing and letter can be found here.
- A letter to the Copyright Office, filed in September 2015, briefly addressing comments filed by the Food and Drug Administration, after the Copyright Office solicited the FDA’s input.
Several Cyberlaw Clinic students and interns were involved in the rulemaking, spanning the Fall 2014, Winter 2015, and Spring 2015 semesters, as well as the Summer 2015 internship program. These students were Sarah Baugh (HLS ’16), Jonathan Diaz (HLS ’16), Evita Grant (HLS ’16), Megan Michaels (HLS ’16), Joo-Young Rognile (HLS ’15), Michael Rosenbloom (Columbia Law ’17), and Shudan Shen (HLS ’16).