Overview
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.
Filings
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.
DMCA Anti-Circumvention Exemption Petition (2014-15)
PETITION OF A COALITION OF MEDICAL DEVICE RESEARCHERS FOR EXEMPTION TO PROHIBITION ON CIRCUMVENTION OF COPYRIGHT PROTECTION SYSTEMS FOR ACCESS CONTROL TECHNOLOGIES | DMCA Anti-Circumvention Exemption Request on behalf of Hugo Campos, Jerome Radcliffe, Karen Sandler, and Benjamin West (No. 2014-07) | November 3, 2014 | The Cyberlaw Clinic submitted this petition (PDF) on behalf of a coalition of medical device researchers as part of the Copyright Office and Library of Congress’ sixth triennial rulemaking process, seeking an exemption to 17 U.S.C. § 1201(a)(1)(A) for those who access the source code and outputs of medical devices in order to research the safety, security, and effectiveness of such devices. (more…)
- 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.
DMCA Anti-Circumvention Exemption Comments (2014-15)
COMMENT AND REPLY COMMENT OF A COALITION OF MEDICAL DEVICE RESEARCHERS FOR EXEMPTION TO PROHIBITION ON CIRCUMVENTION OF COPYRIGHT PROTECTION SYSTEMS FOR ACCESS CONTROL TECHNOLOGIES | DMCA Anti-Circumvention Exemption Request on behalf of Hugo Campos, Jerome Radcliffe, Karen Sandler, and Benjamin West (No. 2014-07) | February 6, 2015; May 1, 2015 | Following the submission in November 2014 of a petition on behalf of a coalition of medical device researchers, the Cyberlaw Clinic submitted an initial comment and reply comment on behalf of that coalition as part of the Copyright Office and Library of Congress’ sixth triennial rulemaking process. (more…)
- 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.
Student involvement
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).
Blog Posts
Cyberlaw Clinic files Petition on Behalf of Medical Device Researchers at the Copyright Office
The Cyberlaw Clinic has filed a petition on behalf of a coalition of medical device researchers as part of the Copyright Office and Library of Congress’ rulemaking for exemptions to copyright’s anti-circumvention law. Every three years the Librarian of Congress, at the recommendation of the Register of Copyrights, considers exemptions to the general law against circumventing technological measures that prevent the public from accessing copyrighted works. These exemptions are granted in cases where the law against circumventing technological measures around copyrighted works unduly impedes on lawful uses of those works. (For more on anti-circumvention law, see the Chilling Effects FAQ.) (more…)
Defending Research into Medical Devices
On Friday, the Cyberlaw Clinic filed a comment on behalf of a coalition of medical device researchers in the Library of Congress’s triennial rulemaking regarding the Digital Millennium Copyright Act’s anticircumvention provisions. As we noted in the blog post from when the Clinic filed an initial petition in this rulemaking, every three years the Librarian of Congress, at the recommendation of the Register of Copyrights, considers exemptions to the general law against circumventing technological measures that prevent the public from accessing copyrighted works. These exemptions are granted in cases where the law against circumventing technological measures around copyrighted works unduly prevents the public from making lawful uses of those works. (For more on anti-circumvention law, see the Chilling Effects FAQ.) (more…)
Protecting Independent Medical Device Research
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.
DMCA Exemption Granted for Med Device Research, Patient Access to Data
We are happy to report that the Library of Congress has approved of exemptions to the DMCA’s anti-circumvention provisions in order to protect independent medical device safety and security research and patient access to data. This announcement comes after a year of litigating this issue before the Copyright Office. You can review all of our prior coverage and the filings of the case at our page about the 2015 Anticircumvention Rulemaking. I wanted to take time to review the decision, and reflect briefly on the process of the DMCA rulemaking. (more…)
