Key Factors
- The Department of Health & Human Services (HHS) is responsible for promoting ethical AI advancement, growth, and utilization, which includes mitigating potential risks linked to AI-driven technologies in healthcare and the integration of AI in pharmaceutical development. President Biden eagerly anticipates the executive order (EO) concerning artificial intelligence (AI).
- Entrepreneurship directs HHS on establishing an AI Task Force, devising a strategy for AI assurance, exploring avenues to enhance equity regulations, formulating an AI safety protocol, strategizing AI implementation in pharmaceutical development, and providing grants to foster AI innovation while ensuring responsible AI deployment.
- The EO mandates HHS to oversee AI applications in areas beyond FDA jurisdiction and to complement the regulatory efforts undertaken by the Food and Drug Administration (FDA) in governing AI.
Overview
The Biden Administration unveiled a comprehensive Entrepreneurship on October 30, 2023, focusing on the Secure and Trustworthy Development and Deployment of Artificial Intelligence, encompassing guidelines pertinent to AI utilization across various sectors, notably healthcare. This article delves into the Entrepreneurship directives relevant to the healthcare domain, previously discussed in detail.
The Entrepreneurship under the Biden Administration aims to strike a balance between harnessing AI’s transformative potential across industries and averting unintended repercussions. This stance aligns with the FDA’s ongoing initiatives, emphasizing the formulation of AI-specific strategies. Additionally, the Office of the National Coordinator for Health Information Technology (ONC) proposed a holistic Health IT Certification Program targeting “predictive decision support interventions,” as previously outlined.
The integration of AI into healthcare, akin to other sectors, is rapidly progressing, surpassing national endeavors to regulate its utilization. Notably, in 2021, AI/machine learning (ML) was incorporated into multiple iterations for over 100 pharmaceuticals and biologicals submitted to the FDA, with the FDA reviewing 171 AIorML-supported health products as of October 19, 2023. The FDA underscores the imperative of long-term safety monitoring and real-world efficacy assessment for AI-driven technologies, advocating for the incorporation of ethical principles, safety protocols, and privacy standards throughout the software development lifecycle. The EO encompasses directives addressing these crucial aspects.
Apart from collaborating with the FDA, HHS is poised to engage various entities and agencies such as ONC, the Office for Civil Rights, Centers for Medicare & Medicaid Services, National Institutes of Health, and Office for Human Research Protections to execute diverse EO mandates. In addition to HHS-led initiatives, the EO emphasizes substantial inter-agency collaboration.
Guidelines for HHS Entrepreneurship
The Entrepreneurship outlines the following guidelines, urging HHS to foster AI advancement while safeguarding consumers, clients, and employees:
Impactful Entrepreneurship Directives on the Healthcare Sector
One significant directive within the EO mandates federal agencies to deploy privacy-enhancing technologies (PETs) as deemed appropriate, a directive spanning all sectors with a pronounced impact on healthcare. Policies governing AI in security and critical infrastructure will also reverberate across the healthcare landscape. Moreover, certain stipulations, like the mandate for developers of “dual-apply foundation models” to furnish reports to the Commerce Department delineating their training and testing methodologies, directly affect private enterprises, including those in healthcare.
Furthermore, several overarching guiding principles articulated in the EO hold particular relevance for healthcare. For instance, the primary tenet underscores the necessity for AI to be secure and trustworthy, resonating deeply within the healthcare domain. The Entrepreneurship underscores the need for robust and standardized evaluations of AI systems to identify, comprehend, and mitigate risks before their deployment to fulfill this objective. The EO accentuates the necessity for testing, evaluations, and post-deployment performance monitoring to ensure the intended functionality, resilience against misuse, ethical development, safe operation, and compliance with pertinent regulations of AI systems.
The guiding principles also address privacy concerns, underscoring the continued applicability of relevant privacy regulations in the AI realm. The Entrepreneurship affirms that the government will enforce existing statutes and implement safeguards against privacy infringements, particularly vital in healthcare where AI errors or misuse could harm patients. It further notes that prevailing frameworks like HIPAA, HITECH, and the FTC Act may persist in governing data handled, transmitted, or processed by AI systems.
Additionally, the Entrepreneurship encompasses directives concerning synthetic nucleic acids, tasking the Director of the Office of Science and Technology Policy, in collaboration with the HHS Secretary among others, to devise a framework promoting the adoption of comprehensive, adaptable, and verifiable chemical nucleic acid procurement screening mechanisms by synthetic nucleic acid providers within 180 days. The EO mandates the Secretary of Commerce, in consultation with the HHS Secretary among others, to initiate an engagement within 180 days with industry stakeholders to formulate specifications for efficient nucleic acid synthesis procurement screening and best practices for managing sequence-of-concern databases to bolster screening. Furthermore, within 180 days of establishing this framework, all agencies funding life sciences research must demonstrate adherence to the procurement guidelines as a funding prerequisite.
Future Steps
The Entrepreneurship presents avenues for engaging stakeholders on AI-related healthcare and life sciences issues. For instance, the EO advocates collaboration with relevant private sector entities through HHS programs to advance AI-enabled tools for crafting personalized immunological-response profiles for patients.
The Akin Health Care & Life Sciences group routinely advises clients involved in developing AI/ML technologies and will monitor national endeavors aimed at regulating AI usage, including the implementation of this EO.
