Trimedx featured in MedTech Insight article examining right-to-repair protections
Jason Henley, president of cybersecurity at Trimedx, was interviewed for a MedTech Insight article examining the debate over medical device right-to-repair protections. Henley outlined Trimedx’s support for continuing the exemption that allows qualified independent servicers to access software and tools needed to maintain and repair medical devices–which helps health systems reduce downtime, control costs, and provide safe & timely patient care.
AdvaMed is urging the US Copyright Office not to renew an exemption allowing independent servicers to repair medical devices. AdvaMed cites intellectual-property, safety and cybersecurity concerns, while Trimedx argues the exemption helps ensure timely repairs and hospitals choice.
The medtech industry’s largest trade group is urging the US government not to renew a copyright exemption that allows third parties to bypass software protections to repair medical devices.
The Advanced Medical Technology Association (AdvaMed) contends that the “Medical Devices—Diagnosis, Maintenance, or Repair” exemption, established under the Digital Millennium Copyright Act (DMCA) in October 2021, has harmed medical device manufacturers.
The exemption allows third-party technicians to circumvent software access controls on medical devices when necessary for diagnosis, maintenance or repair.
In comments submitted to the US Copyright Office on Sept. 28, AdvaMed argued that manufacturers’ service software has independent commercial value and that restricting third-party access is necessary to protect intellectual property, device safety and cybersecurity.
The comments responded to petitions from eight independent medical-device service organizations and affiliates supporting renewal: Trimedx, Brown’s Medical Imaging, Caylor Equipment Services, Crothall Facilities Management/Intelas, East Coast Medical Systems, iFixit, ImageOne Medical Group and Marshall R. Shannon.
AdvaMed’s opposition follows a federal appeals court decision that upheld the exemption, rejecting a challenge from the trade group and the Medical Imaging Technology Alliance.
In its ruling, the DC Circuit upheld the exemption as the Copyright Office began its 10th triennial review of DMCA exemptions. The existing exemption is set to remain in effect through October 2027.
The court concluded that the Copyright Office had followed proper administrative procedures in establishing the exemption and that its decision was supported by fair-use principles under copyright law.
Fundamental changes
AdvaMed argues that the exemption fails to distinguish dedicated repair software from clinical-operation software and should be reconsidered through a new rulemaking process. The trade group also contends that the exemption no longer reflects changes in medical-device technology and how manufacturers provide service tools.
AdvaMed noted that the appeals court rejected its challenge “for want of proof, not for want of merit.” The court found that AdvaMed had not established a distinct body of repair software separate from clinical-operation software or demonstrated that it occupied its own standalone market.
AdvaMed said the ruling “is not an endorsement of the exemption’s application to servicing and diagnostic works” but instead reflected an insufficient evidentiary record.
“As long as the exemption stands, third-party servicers may utilize it as a rationale for infringing manufacturers’ copyrights.”
In its Copyright Office submission, AdvaMed said it had gathered new firsthand evidence from medical-device manufacturers showing that servicing and diagnostic software, along with maintenance-related documentation, are distinct from the clinical-operation software used by clinicians.
The association said the evidence established three facts: servicing works are distinct from clinical-operation software; they are protected by technological controls with different purposes and administrators; and original equipment manufacturers (OEMs) license or use them in separate commercial service markets, including in competition with independent service organizations.
AdvaMed defines explains that “servicing works” refers collectively to “System Servicing/Diagnostic Software and Maintenance-Related Documentation.”
The trade group cited evidence from Carestream, GE HealthCare, Hologic, Philips and Siemens Healthineers distinguishing software used to operate medical devices from tools designed for servicing and repair. AdvaMed says these tools, which include diagnostic programs, calibration software, and configuration utilities, are subject to separate access controls and, in some cases, separate licensing arrangements.
AdvaMed also argued that independent servicers using dedicated service software for its intended purpose—repairing a device—were not making a transformative use of the software. Its exhibits cited manufacturers’ use of service keys, smartcards, license keys and other credentials to control access to servicing tools.
“As long as the exemption stands, third-party servicers may utilize it as a rationale for infringing manufacturers’ copyrights,” AdvaMed said.
Exemption support
Trimedx, one of the eight organizations supporting renewal, argues that independent servicers need access to medical-device software and diagnostic tools to provide timely, cost-effective repairs.
Jason Henley, president of cybersecurity at Trimedx, told Medtech Insight that failure to renew the exemption could limit hospitals’ options for diagnosing, maintaining and repairing software-enabled equipment.
Henley noted that restrictions on access to software, data, manuals and other service resources could prolong downtime, increase costs and reduce device availability, directly affecting patient care.
“An otherwise qualified independent technician may need to coordinate with the manufacturer, which can delay the repair process,” Henley said, adding technicians may need access to diagnostic software, service modes, error logs and calibration functions to identify problems and return equipment to clinical use.
In emergency situations, qualified technicians should have an appropriate means of accessing software needed for lawful diagnosis, maintenance and repair, provided they comply with applicable safety, testing, documentation and regulatory requirements, Henley said, noting that technicians must also verify that equipment is safe and functioning properly before returning it to clinical use.
Trimedx filed a petition in August to the Copyright Office supporting continuation of the exemption.
In that filing, Trimedx says that to effectively provide service, it must be able to access and utilize both the medical devices themselves and “any related service materials” that provide information necessary for the required maintenance and repair of those devices.
“Unfortunately, OEMs often preclude and/or make such access difficult, forcing hospitals and third-party servicers to accept higher costs, longer service delays, and reduced autonomy over their own equipment,” Trimedx says. “OEM restrictions on repair access take many forms, including denial of access to service manuals, diagnostic and calibration software, proprietary software keys and licensing, restrictions on parts availability, specialized tools, and training. By their very nature, these restrictions are anti-competitive and designed to protect manufacturers’ revenue, not to advance patient safety or public interest.”
In its petition, AdvaMed asked the Copyright Office to reject streamlined renewal of the exemption. Alternatively, it requested the office to exclude separately controlled and separately licensed servicing software and documentation and consider the issue through a new public rulemaking.
The exemption remains in effect while the Copyright Office reviews the competing submissions.
Medtech Insight reached out to AdvaMed for comment on emergency repairs involving independent technicians and what alternatives it would propose to ensure hospitals have timely access to repairs if the exemption is not renewed.
AdvaMed had not responded by publication time.