QI Podcast: Introduction to IEC 62304


I had the pleasure to discuss with [Oded Assouline](https://www.linkedin.com/in/oded-assouline-29b045135/) on the [QI Podcast](https://www.youtube.com/channel/UCmnn2mgFxT2zCyyejHaLuGQ) about IEC 62304 from an agile software development perspective:

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As a software engineer, I recently had the opportunity to step into the realm of medical conferences. The first-time experience at the European Society of Human Reproduction and Embryology (ESHRE) Congress, where I was honored to be invited as a speaker, is a steep departure from the typical academic or tech industry events that I’m accustomed to.

Although branded European, the event had a global reach with more than 10000 participants coming from all corners of the globe. I had the privilege to contribute my talk about the certification of artificial intelligence to the pre-congress course on Artificial Intelligence in Assisted Reproductive Technology (ART).

The course program offered a balanced blend of technical and domain-specific discussions. As anticipated in an AI-focused event, the technical sessions delved into algorithms and regulatory procedures associated with medical devices and software. However, it was the ART-related talks that truly caught me by surprise. Despite the abundance of medical terminology and copious amounts of data, which presented a challenge to comprehend fully, I was captivated by the profound mastery of the mathematical underpinnings that form the foundation of AI technology.

The speakers, primarily professionals from reproductive clinics, exhibited a remarkable expertise within their domain. However, their fluency in the AI jargon commonly used in the tech industry was limited. Consequently, the latest advancements in generative AI, particularly large language models (LLMs), appeared intimidating to them. The incorporation of AI-related technologies within clinical settings posed a significant challenge, particularly when considering the complex regulatory landscape. Surprisingly, for someone familiar with regulatory intricacies, the field of human reproduction presents even greater complexities in terms of both regulations and ethical considerations. Adding to the complexity, these issues varied substantially across jurisdictions, imposing significant limitations on practitioners and affecting their ability to collaborate on the development of novel technical solutions.

The course program concluded with an engaging panel discussion that fostered active participation from both the presenters and the audience. The conversation revolved around several overarching themes, such as the perceived gap between practitioners and technology within the field of reproductive medicine, and strategies to enhance cooperation. A notable challenge highlighted was the absence of shared reference databases, which hinders dissemination of best practices. Similarly, interoperability issues between tools lead to fragmented workflows. However, the potential solution of leveraging the Fast Healthcare Interoperability Resources (FHIR) standard was proposed as a means to address this challenge. Perhaps the most significant point of contention focused on the ethical considerations surrounding the use of AI in human reproduction. Ultimately, the consensus was reached that it is ethically unjustifiable to not harness the power of AI in this domain, emphasizing the imperative to integrate AI technologies responsibly and ethically.

Thanks [Sara Zdravka Veleva](https://www.linkedin.com/in/sara-zdravka-veleva-7a2b3517) and [José Alarcón Roldán](https://www.linkedin.com/in/alarconroldan) for inviting me to this great event! I surely enjoyed it!

A software engineer goes to ESHRE...


What was only a dream last August, has now became a real RegOps Days conference and community. With RegOps, we share an interest in integrating regulation activities into DevOps practices. It all started during a discussion over a pizza with [Tommi Mikkonen](https://www.linkedin.com/in/tommimikkonen). We talked about the state of regulatory work in today's fast pacing DevOps practicing organisations. Our first thought was to cover the topic with a guest lecture at Helsinki University, but we soon realised that that was not a good forum to approach this topic. The exposure to regulatory work is quite limited among students. The idea of having a conference was born! It would provide a venue where researchers and practitioners could meet. There, they can exchange ideas and experiences about their areas of expertise. Things were getting serious. We reached out to our friends at [Osaango](https://www.linkedin.com/company/osaango), and [Marjukka Niinioja](https://www.linkedin.com/in/marjukkaniinioja) jumped in to help.

So here we are: February 13th in Tiedekulma at [RegOps Days Helsinki 2020](https://www.regopsdays.org/). Roughly 50 participants representing more that 20 organisations with an interest in regulated medical device software development. Needless to say, excitement was high. Over the course of the morning we listened to four engaging presentations.

The first talk was held by Mauri Honkanen from Avaa. He explored the thin line that separates wellness and medical applications. Medical regulations cast a much larger shadow as they influence expectations and decision making beyond their intended target. Next, I've talked about the challenges caused by using agile development in regulated environments. A practical way to reduce these challenges is to perform RegOps during pull requests. The timing enables compliance officers to be in sync with the rest of the development team. The coffee break and the cinnamon buns gave the energy boost for the next two talks. Risto Kaikkoinen described Solita's journey into becoming a medical device manufacturer. He gave practical advice on how an experienced software organization handles regulations. The last presentation was by Ilari Richardt from Terveystalo. He described the challenges his organization faces developing in parallel several regulated products.

The conference concluded with a lively panel discussion focused around the following topics:

- The importance of RegOps
- The biggest challenges hindering RegOps adoption
- The relations of medical regulatory practices with other regulated industries
- The need for having a community of practice around RegOps

Besides these topics, we explored the role of academia in fulfilling these needs. Universities need to step up and prepare the students for a new workplace governed by regulations. The discipline required to develop regulated software products is the rule rather than the exception. Understanding that behind regulatory activities are best practices is of upmost importance. The acquired skills are applicable across many application domains, making them more valuable.

The recent evolutions in artificial intelligence and machine learning were also touched. Their use raises interesting questions from a regulatory perspective. Datasets play an important role for the development of new algorithms and models. What is their origin? How do they change over time? The consensus was that new regulatory practices will emerge to cover data lifecycle. Someone even suggested the term DataOps.

While the panelists gave interesting insights into these topics, the real heroes were the participants. They asked questions and engaged into lively conversations. The distance between the stage and the audience disappeared. This created a meetup-like vibe to the whole event.

Last but not least, an event like this does not happen without help from our emerging community. Big thanks to [Citrus](https://www.citrus.fi/) for supporting us at the beginning of this journey. Nice to have them as first RegOps Days event sponsor. [Techie Stories](https://www.techiestories.com/) filmed the talks and the panel discussion. The videos allows us to reach the community members that were not able to join us this time.

Looking forward, the feedback from this event participants looks solid. RegOps discussions will continue in community events like meet-ups. Their scope might cover other regulation intensive industries such as finance or automotive. Keep an eye on the RegOps [website](https://www.regopsdays.org/) for upcoming events and register for our newsletter.


First impressions from RegOps Days 2020 conference, topics discussed and the way forward