{"id":17858,"date":"2015-10-28T14:10:37","date_gmt":"2015-10-28T18:10:37","guid":{"rendered":"http:\/\/pmedicine.org\/epatients\/?p=17858"},"modified":"2015-10-28T14:10:37","modified_gmt":"2015-10-28T18:10:37","slug":"key-legal-victory-moves-medical-device-patients-one-small-step-closer-to-full-access-to-their-data","status":"publish","type":"post","link":"https:\/\/participatorymedicine.org\/epatients\/2015\/10\/key-legal-victory-moves-medical-device-patients-one-small-step-closer-to-full-access-to-their-data.html","title":{"rendered":"Key legal victory moves medical device patients one small step closer to full access to their data"},"content":{"rendered":"

\"Hugo<\/a>For whose benefit does the healthcare industry exist? For the investors, or the people whose needs are the reason for the industry?<\/p>\n

Facebook last night was celebrating a small but significant legal victory this week for the \u201cgimme my DaM data\u201d movement (\u201cData about Me\u201d), of whom super-e-patient Hugo Campos is a well known example.<\/p>\n

Regular readers are well aware of Hugo\u2019s odyssey (search his name on this blog<\/a>) to get his hands on the data that\u2019s gathered and emitted by the ICD (implantable cardioverter-defibrillator) that\u2019s wired into his heart. For years he\u2019s tried to get that data, but device maker Medtronic has said \u201cSorry, you\u2019re not our customer. Your doctor is.\u201d And, whether we like it or not, the vendor has a legal right to protect its patented and copyrighted designs and software.<\/p>\n

The ruling, from the Copyright Office (under the Library of Congress), grants the plaintiffs (four \u201cpatient researchers,\u201d including Hugo) an exception that allows them to circumvent that vendor\u2019s \u201ctechnological protection measures\u201d that effectively limits access to copyrighted work, in this case the software that runs a patient\u2019s medical device and the data it collects<\/p>\n

Note: this is a far cry from what e-patient advocates really want (medical device interoperability, standardized data formats, and better data access through open APIs) to help pave the way toward transparency, which is critical for patients to know what\u2019s happening in their bodies.<\/p>\n

They still have to do all the work to get and interpret the data. But this ruling means they can no longer get in trouble for trying –\u00a0at least not for the next 3 years (see this tweet)<\/a>, when, unbelievably, they have to repeat the request. And remember: every one of the manufacturers\u2019 arguments about piracy or copyright infringement was rejected as having no basis in reality.<\/p>\n

The story is complex, Hugo says, so in the interest of speed, I\u2019ll just quote from this blog post from the Cyberlaw Clinic at Harvard\u2019s Berkman Center for Internet and Society, which argued the case:<\/p>\n

The Cyberlaw Clinic represented a coalition of medical device researchers \u2013 Hugo Campos, Jay Radcliffe, Karen Sandler, and Ben West \u2013 who study the safety, security, and effectiveness of implanted medical devices. Some of our clients study this by analyzing the software of medical devices for vulnerabilities or flaws, and others look specifically to how patients can protect themselves by getting more timely access to medical data.<\/p>\n

Through a petition, initial comment, reply comment, and two subsequent letters, the Clinic articulated why such research is vital to ensuring patient health and safety, does not seriously risk piracy or infringement, and should be allowed to continue …<\/p><\/blockquote>\n

Here\u2019s what Hugo said about what the decision means, on Facebook:<\/p>\n

This ruling means a researcher patient can circumvent a manufacturer’s copyright protections measures (for example to reverse engineer a device) to gain access to his data or independently verify the safety and efficacy of his device without breaking the law.<\/p><\/blockquote>\n

It\u2019s a first step but a big one, because strenuous industry objections were rejected and the decision seems to agree with the patients\u2019 perspective, as shown in the italicized excerpts in that Berkman post. Much more will be written in the coming weeks, I\u2019m sure.<\/p>\n

Congratulations to Hugo and his colleagues, and many many many thanks to the Berkman Center\u2019s Cyberlaw Clinic, who argued the case – with a full year of effort.<\/p>\n

One more thing: for a chilling hint of how far industry will go to protect its interests, over the interests of the patients they\u2019re supposedly serving, consider this from the end of the Berkman post: (emphasis added)<\/p>\n

While the Clinic is quite happy that it was able to persuade the NTIA, Copyright Office, and Library of Congress to grant this exemption and secure this victory for our clients, it was not without tremendous effort<\/strong>. The work spanned a full calendar year,<\/strong> and involved the help of seven different Clinic students and interns \u2026<\/p>\n

And for all of that time and extensive record building, the opponents to the exemption never once were able to show<\/strong> how this sort of [patient] research would violate copyright law, or risk greater piracy of medical devices.<\/strong> That fact alone should have ended this inquiry before it began.<\/p><\/blockquote>\n

Indeed, for whose benefit does this industry exist?<\/p>\n

And why should it take seven Harvard Law students and interns a year to fight those who are putting their interests ahead of the patients they say they serve?<\/p>\n

________________<\/p>\n

Further background:<\/em><\/p>\n