There are other key provisions in the legislation designed to facilitate equipment repair. Provisions in existing contracts with manufacturers are to be deemed null and void during the emergency if they prohibit or restrict repair or maintenance options for the healthcare provider. There is even a provision which permits a covered healthcare provider to fabricate a part on a non-commercial basis, and as needed, for the repair or maintenance of critical medical infrastructure. The legislation is silent as to whether other regulatory authorities such as the FDA may have to be notified, as presumably, the FDA could perceive these actions as some form of adulteration of the device and need to weigh in on safety issues.
The legislation also states that it is not a violation of the copyright law for a covered healthcare provider to manufacture, import, or otherwise traffic in technological means to circumvent a technological measure that effectively controls access to a work protected under the copyright laws if that action by a covered healthcare provider enables a repair or maintenance permitted under this legislation to occur.
The U.S. Federal Trade Commission is charged under the proposed legislation with promulgation of regulations and enforcement. Violations of this act and any rule-making will be treated under the legislation as unfair or deceptive acts or practices under existing FTC laws and regulations. Manufacturers would presumably be monitored by the FTC for compliance with the legislation or at least wary that conduct violative of this legislation could be reported by the hospitals or their agents. The legislation also calls for the FTC to conduct a study within one year regarding the impact and effectiveness of the Act, with respect to innovation and anti-competitive practices in the market and enforcement.
Some industry thought leaders, while applauding this legislation, have noted that this legislation, if adopted, would be in effect for a limited period of time.
“This legislation is a good first step during the pandemic," said Marc Schaefer, president of Alabama-based Medical Imaging Systems. "We do feel that this level of access needs to be granted permanently and not just for a crisis. In many ways you add to the crisis by limiting supporting information.” Schaefer added, “all discussions on healthcare should start with one focus: will this affect the patient? Greater cooperation [on access] means more resources for better patient outcomes.”
As Jimmy Kallam, president of East Coast Medical, observes, “it should always just be about helping the patient.”