Category: RCL Blogs

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.

Aristotle once said, “The more things change, the more they stay the same.” In his quest to discover the true meaning of life, he firmly believed that the universe is in a constant state of motion — always changing, always evolving. In other words, what it’s like today is never the same as tomorrow. However, he also believed in another idea that always remains constant in everything, entelechy. He preached that everything one faces must have a purpose because it gradually turns them into the person they are destined to be.

Likewise, I believe everything happens for a reason too. Whether it’s being excluded from your friend circle or forced to run silly, time-wasting errands throughout the day, there’s often an underlying reason that most of us fail to realize. Take as an example the time my family found small water spots within our attic. To better understand if these spots were signs of water leakage from old or damaged roof shingles, we needed to have a bird’s-eye view of our roof. Using a small old remote-controlled helicopter toy, an Arduino (a microcontroller platform that controls specialized pieces of hardware using code), a tiny camera module, a power module, and a storage module, I built a makeshift drone for practically free. Coming up with the idea was the easy part, but executing it proved to be the real challenge. I started by building a functional video component on the original Arduino board. Then, incrementally, I tried to enable video recording with the camera and storage module. Lastly, I tried attaching all the modules to the toy helicopter in a way that would still enable the helicopter to achieve liftoff with the additional weight. Ultimately, this new gadget let me see my roof, record the entire flight, and examine the recorded footage at various magnification settings. We found there to be no distinctly misplaced or damaged shingle, but it did give me the chance to play with some new Arduino components.

Had there never been any water spots to begin with, I wouldn’t have been able to step out of my comfort zone and learn more about how Arduino components work together in a system. Put another way, the leak in our roof happened so that I could explore and discover different avenues on how to come up with a solution — a test of my ability, if you will.

As such, it’s imperative we change our outlook on how we view everyday occurrences in our daily lives, shifting towards adopting a rational mindset. If someone’s ignoring you, then you don’t have all the details yet and there’s likely to be a good reason. I believe everything happens for a reason, no matter how silly, small, or vague.

(I know the end sounds abrupt, and I need to fix it.)

For this semester, I plan on writing my Passion blogs on surreal natural phenomena that occur in the world (e.g., moonbows, shooting stars, whirlpools, etc.). As for my Civic Issues blog, I plan on writing about starvation concerns and global hunger in today’s society. I look forward to getting started next week!