2015 Anticircumvention Rulemaking Proceeding

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)

1201rulemakingcoverPETITION 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…)

DMCA Anti-Circumvention Exemption Comments (2014-15)

Reply Comment Cover PageComment Cover PageCOMMENT 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…)

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

Copyright OfficeThe 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

pacemaker 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

IMG_0614Over 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.

(more…)

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…)