Overview
Title
To regulate electronic medical device use in secure compartmented information facilities, to require the Director of the National Intelligence oversee transparency reporting and related initiatives, to encourage investment in modernization efforts for sensitive compartmented information facilities, and for other purposes.
ELI5 AI
The CLEARED Act of 2024 is a rule that says special rules should be made for using medical gadgets like heart monitors in secret government buildings to keep everyone safe. It also says someone should check these gadgets to make sure they follow the rules.
Summary AI
The CLEARED Act of 2024 aims to regulate the use of electronic medical devices within secure government facilities known as secure compartmented information facilities (SCIFs). It requires government entities managing SCIFs to track and report approvals or denials of these devices and mandates creating a policy for their use. The Act also establishes an Electronic Medical Device Governance Board to oversee security reviews, maintain a public database of device approvals, and provide recommendations to improve device management. Additionally, it ensures the protection of personal and medical information.
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AnalysisAI
General Summary of the Bill
The "Cleared Locations Enabling Access to Relevant Essential Devices Act of 2024" or the "CLEARED Act of 2024" proposes regulations affecting electronic medical device use in secure information facilities. The bill mandates transparency and modernization within these highly sensitive environments, known officially as secure compartmented information facilities (SCIFs). It requires designated government entities to develop comprehensive policies, keep detailed records of electronic medical device approvals and denials, and create publicly accessible databases outlining these decisions. Furthermore, the bill places oversight responsibilities on the Director of National Intelligence and establishes a Governance Board to monitor and standardize the process.
Summary of Significant Issues
Several issues arise from the bill's current language and potential implementation. First, there's concern that the lack of specific funding or budget considerations could place a financial burden on entities responsible for compliance, leading to unfunded mandates. Another area of concern is the bill's reliance on an existing directive ("Intelligence Community Directive 124") to define what constitutes an electronic medical device, which may not be readily accessible to all stakeholders, leading to potential misunderstandings or inconsistent application of the law.
Additionally, while the bill calls for a publicly accessible database, it simultaneously raises issues of confidentiality, as determining which information should remain classified versus unclassified could pose challenges. This complexity is compounded by the omission of explicit definitions for key terms, such as "secure compartmented information facility," which could result in misapplication or confusion about the bill’s intended scope.
Impact on the Public and Stakeholders
This legislation has broad implications, both positive and negative. By increasing transparency and standardizing the approach to electronic medical device approval, it potentially enhances national security and operational efficiency in SCIFs. This transparency could build public trust in sensitive governmental operations, providing reassurance that security is being maintained without compromising medical needs.
However, the potential financial and administrative burden on government entities could divert resources from other critical areas. Stakeholders such as government employees working within these facilities may benefit from clearer guidelines and structured processes, but they could also face operational slowdowns as new administrative procedures are established and refined.
Healthcare professionals and electronic medical device manufacturers might view the legislation with mixed feelings. The requirement for disclosure and approval tracking could enhance trust and validation in medical device use. Conversely, concerns about privacy protection and the potential exposure of sensitive operational details could deter innovation or participation in government-associated projects.
In summary, while the CLEARED Act of 2024 aims to modernize and regulate the usage of electronic medical devices within high-security environments, its practical implementation might face significant challenges regarding budget allocation, privacy concerns, and the potential for operational inefficiencies. The bill attempts to balance national security needs with individual rights to medical access, providing an intricate framework that requires careful consideration and resourceful execution.
Issues
The bill does not provide specific funding or budget considerations for developing and maintaining electronic medical device ledgers and databases, which may lead to unfunded mandates for covered entities. This could result in financial burdens on entities required to comply with the reporting and database maintenance requirements. (Section 2(b)(1), Section 2(b)(2))
The definition of 'electronic medical device' relies on Intelligence Community Directive 124, which may not be widely available or understood by all stakeholders. This could lead to confusion and inconsistent interpretation or implementation of the bill. (Section 2(a)(2))
The requirement for an unclassified list to the maximum extent practicable with a classified annex may lead to challenges in determining what information should remain classified, potentially risking the exposure of sensitive information. (Section 2(b)(2)(B))
The bill implies the involvement of the Governance Board in technical risk assessments but does not clarify if additional specialized personnel or resources will be required, which could create operational challenges. (Section 2(c)(2)(D))
The mandate for covered entities to submit various documents to the Governance Board and the Director of National Intelligence could create an administrative burden without clear resource allocation, impacting the efficiency of governmental operations. (Section 2(b)(4))
While protection of personally identifiable information is mentioned, the bill lacks detailed protocols or guidelines for ensuring such protection, which could lead to privacy concerns and potential legal challenges. (Section 2(d))
The expectation for the database to be publicly accessible may raise concerns about the confidentiality and security of sensitive information, which could have implications for national security and privacy. (Section 2(c)(3))
The term 'secure compartmented information facility' is used frequently but is not defined within the section, potentially leading to confusion about the scope of the facilities affected by this bill. (Section 2(a)(1))
Sections
Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.
1. Short title Read Opens in new tab
Summary AI
The first section of the act states that the official name of the legislation is the "Cleared Locations Enabling Access to Relevant Essential Devices Act of 2024," which can also be abbreviated as the "CLEARED Act of 2024."
2. Enhancing National Accessibility for Better Long-term Employment Act of 2024 Read Opens in new tab
Summary AI
The "Enhancing National Accessibility for Better Long-term Employment Act of 2024" requires government-affiliated entities managing secure facilities to keep track of electronic medical device approvals and denials, create policies and lists about their use, and submit reports to a Governance Board and the Director of National Intelligence. The act also mandates developing a public database of approved or denied devices to ensure transparency and address security and privacy concerns.