Policy Regulations and Standards - An Introduction

Policy, Regulations And Standards

Artificial intelligence (AI) has had its ups and downs over the past several decades, but most recently, we are seeing its evolution within the healthcare industry. The disruptive potential of artificial intelligence and the role it should play within healthcare are issues that governments and organizations alike are grappling over how to handle. Regardless of the industry, we have to ensure that regulations are in place to guide the creation, and subsequent deployment, of AI models.

AI has the potential to both positively and negatively transform patients’ lives and the healthcare system. Understanding the importance of proactively addressing key considerations, such as regulation, standards, and safety, we have now seen an acceleration in the number of AI-focused policies, frameworks, task forces, organizations, and regulatory bodies created to help address this need. The political, regulatory, and economic landscape is both affected by and exerts influence on the development and use of AI within healthcare. Although we are still in the infancy stages of determining the regulatory and strategic infrastructure needed to promote the safe and effective use of AI, many countries have taken on the gargantuan task of creating frameworks for using AI. It is essential to understand what currently exists and how to anticipate what the direct and indirect consequences of any future regulation might be on AI and the changing role of healthcare professionals. Part 3 of this AI series will explore the current landscape and drivers influencing AI regulations, the implications of what is already in place, the vision of key stakeholder organizations, and where significant gaps still exist.

Here are a few quick definitions to help us understand and contextualize the rest of this review:

• Policy: a plan, or course of action, proposed and adopted by a government, organization or institution

• Regulation: refers to rules created and administered by governmental agencies and enforceable by law

• Standard: specifications to give direction to what is expected of a certain product, system or service, to guide best practices across different groups

The current policy and research landscape of AI is an evolving patchwork. Currently, a broad and somewhat disjointed array of AI policies has set the backdrop upon which we are beginning to see new AI regulations or laws. We can think of policies as the overall courses of action proposed and adopted by governments, organizations, or other institutions. Regulation, on the other hand, often follows public policy and in this article, we use the term to refer to the compulsory laws governing a given domain as opposed to general recommendations. Lastly, standards refer to a shared definition for a product, system, service or terminology used across different groups. As you will see, all three play essential roles in determining the future of AI research, development, and ultimate use within healthcare.