“I’ve talked to over a hundred biomeds since the start of the crisis — all they want is to be able to fix broken equipment and protect the patients in their hospitals," said U.S. P.I.R.G. Right-to-Repair advocate Kevin O’Reilly. "By giving these frontline workers access to service materials, Sen. Wyden’s bill helps them get their job done.”
The legislation encompasses not just biomeds, but includes “any person engaged in the diagnosis of problems with respect to, or the service, maintenance, or repair, of critical medical infrastructure.” It provides relief from the copyright and patent laws to "covered service providers", which includes an owner or a licensee of a copy of service materials, or their agent.
The bill imposes a duty to disclose service materials upon manufacturers of "critical medical infrastructure" so that hospitals may readily obtain service access information for medical equipment being used for diagnosis and treatment. "Critical medical infrastructure" is defined as, “a device, computer program, or other product or equipment used to provide medical services.”
Service materials when used with respect to "critical medical infrastructure" includes any information or material that the manufacturer provides "directly, indirectly or wirelessly" to technicians of the manufacturer or repair facilities authorized by the manufacturer, and includes:
• Schematics, wiring diagrams, mechanical layouts, and other pertinent data with respect to the critical medical infrastructure;
• Computer programs used in diagnosing problems or in calibrating, repairing, or maintaining the critical medical infrastructure;
• Service keys that are required to access diagnostic information or otherwise authorize repairs;
• Access to error legs that are required to diagnose required repairs;
• Preventive and corrective maintenance, inspection and repair manuals;
• Safety alerts, recalls, service bulletins, specification updates and the need for adjustments to maintain efficiency safety and convenience;
• Any other information provided to diagnose the programs with respect to service, maintain, repair, activate, certify or install;
• Training materials
Manufacturers would be required to provide, on fair and reasonable terms, access to information and tools used to diagnose problems and service. Under the legislation, the information available to a “covered service provider” would include schematics, service keys, error logs, manuals, safety alerts, recalls, specification updates and other information to diagnose problems with respect to repairing critical medical infrastructure.