Introductory Draft of Issue Brief

Regulating Medical Devices with AI Capabilities: Healthcare assistant or tyrant?

The rapid rise of innovative technology is augmenting human capabilities and replacing eons-old activities. Artificial intelligence (AI)-driven systems have particularly spread to more than half of the world’s population in ambient information and connectivity, with new advances constantly being made like DeepMind’s AlphaFold AI-based algorithm that solved a 50-year-old challenge in proteomics. As AI technology continues to evolve at an alarming rate, it’s being integrated with and deployed into a variety of sectors, such as the automotive, finance, manufacturing, retail, and, most notably, the healthcare industry where it has surged in popularity over the past few years. Indeed, medical AI promises to drive tremendous scientific breakthroughs, aid in diagnosis, treatment, and management of diseases, accelerate drug development and delivery, control costs, and support health equity. While some strongly praise this emerging power, others believe its a double-edged sword with potential risks that may bring considerable threats, including potential errors and patient harm; risks of bias and increased health inequalities; lack of transparency and trust; and vulnerability to hacking and data privacy breaches to name a few. Although these reservations likely won’t obstruct its adoption into healthcare in the long run, these are valid points that must be addressed appropriately to ward off exacerbated concerns. The regulatory framework governing these tools is complex. For example, the U.S. Food and Drug Administration (FDA) regulates some AI-enabled products used in healthcare, and the agency plays an important role in ensuring the safety and effectiveness of those products under its jurisdiction. Right now, the agency is considering how to adapt its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways that are difficult to anticipate. Ultimately, it will require a joint effort by key authorities like the FDA, Congress, technology developers, and the healthcare industry to ensure the safety and effectiveness of medical AI-enabled technology, maximizing the benefits while minimizing these risks at the same time.

One thought on “Introductory Draft of Issue Brief”

  1. 1). I really like this title, it’s very powerful and makes me interested in what you have written. It obviously lets the audience know you are focusing on the controversy over the AI presence in the medical field. Using the word tyrant kind of suggests the negativity of the situation even though others may think that AI is a technological achievement for assistance. I honestly don’t think the title needs any changing.

    2). Yes the title as well as the piece definitely respond to an exigence, that being the harmful impacts of AI controlling the medical field. Definitely, I think when the risks brought to patients are mentioned makes this issue that much more pressing than it already is. The unemployment was not even mentioned when that itself is very harmful to all types of industries.

    3). From what I gathered, this was your thesis, “While some strongly praise this emerging power, others believe its a double-edged sword with potential risks that may bring considerable threats, including potential errors and patient harm; risks of bias and increased health inequalities; lack of transparency and trust; and vulnerability to hacking and data privacy breaches to name a few.” It definitely sets up an argumentative essay as it is clear these are the points you are going to back up with evidence and anecdotes. The thesis does not mention the advancement of a certain policy but it was mentioned here, “Ultimately, it will require a joint effort by key authorities like the FDA, Congress, technology developers, and the healthcare industry to ensure the safety and effectiveness of medical AI-enabled technology, maximizing the benefits while minimizing these risks at the same time,” which I think is fine! I can kind of picture where the argument is going to go, but I think the half knowing half not knowing aspect is perfect, I understand what you are trying to get at, but I am still intrigued to read more.

Leave a Reply

Your email address will not be published. Required fields are marked *