In a groundbreaking shift that’s reshaping medical research, universities across North America and Europe are increasingly bypassing traditional ethics reviews for studies involving AI-generated synthetic medical data. According to a recent report in Nature, representatives from four prominent medical research centers—including institutions in Canada, the United States, and Italy—have confirmed they’ve waived standard institutional review board (IRB) approvals for such projects. The rationale? Synthetic data, created by algorithms that mimic real patient records without containing traceable personal information, doesn’t pose the same privacy risks as actual human data. This move is accelerating fields like drug discovery and disease modeling, where access to vast datasets is crucial but often hampered by regulatory hurdles.

Proponents argue that this approach could unlock unprecedented innovation. For instance, AI systems can generate hypothetical patient profiles—complete with symptoms, genetic markers, and treatment outcomes—based on anonymized real-world patterns. Researchers at these centers told Nature that by eliminating the need for lengthy ethics approvals, which can delay projects by months, they’re speeding up trials for rare diseases and personalized medicine. A similar sentiment echoes in a WebProNews analysis, which highlights how synthetic data is being used to train machine-learning models for predicting cancer progression without ever touching sensitive health records.

The Ethical Tightrope: Balancing Speed and Scrutiny in AI-Driven Research
This waiver trend isn’t without controversy, as critics warn it could erode foundational safeguards. Ethical guidelines from the World Health Organization, outlined in their 2024 guidance on AI in healthcare, emphasize the need for governance to address biases in large multi-modal models. If synthetic data inherits flaws from the original datasets—such as underrepresentation of minority groups—it might perpetuate inequities in medical AI, leading to skewed diagnostics or treatments. Posts on X (formerly Twitter) reflect growing public concern, with users debating privacy implications and calling for stricter oversight, often citing fears that “synthetic” doesn’t mean “safe” from algorithmic errors.

Moreover, a 2025 study in Frontiers in Medicine reviews a decade of global AI medical device regulations, noting that while synthetic data sidesteps patient consent issues, it raises questions about accountability. Who verifies the accuracy of AI-generated datasets? In one example from the Nature report, a Canadian university used synthetic data to simulate COVID-19 vaccine responses, bypassing IRB review and completing the study in weeks rather than months. Yet, as another Nature piece cautions, artificially generated data must be rigorously validated to avoid misleading results that could harm real-world applications.

Regulatory Gaps: Calls for Harmonized Standards Amid Rapid AI Adoption
The pushback is intensifying, with experts advocating for updated frameworks. A 2024 article in Humanities and Social Sciences Communications identifies key challenges like health equity and international cooperation, urging harmonized regulations to prevent a patchwork of standards. In the U.S., the FDA has begun scrutinizing AI tools, but synthetic data often falls into a gray area, as noted in PMC’s 2021 overview of AI ethics in medicine. European regulators, influenced by GDPR, are more cautious, yet Italian centers are among those waiving reviews, per Nature.

Industry insiders see this as a double-edged sword: faster research could lead to breakthroughs, but without robust checks, trust in AI healthcare might falter. Recent X discussions amplify this, with tech influencers warning of “bias amplification” in synthetic datasets. As one researcher quoted in WebProNews put it, the shift demands “updated regulations to balance innovation with accountability.” Looking ahead, organizations like WHO are pushing for global guidelines, potentially mandating third-party audits for synthetic data projects.

Future Implications: Navigating Innovation and Risk in a Data-Driven Era
Ultimately, this development signals a broader transformation in how AI intersects with medicine. By 2025, as per Frontiers’ analysis, AI integration in diagnostics is expected to surge, with synthetic data playing a pivotal role. However, ethical lapses could undermine public confidence, especially if biases lead to real harms. Universities must collaborate with regulators to ensure synthetic data’s promise doesn’t come at the cost of integrity, setting a precedent for responsible AI use worldwide.

AI is everywhere, it can be overwhelming, and lots of folks will be sick of hearing about it. But it’s also important to continue to recognize where AI can make a real difference, including in helping our understanding of the universe.

That’s exactly what’s been happening at Oxford University, one of the UK’s most respected academic centers. A new tool built by its researchers is enabling them to find “the needles in a cosmic haystack” while significantly reducing the workload on its scientists conducting the research.

Quick links: Startup Week stats so far | AI tied to 75% of sessions | Colorado Springs budget shortfall | Denver inflation up 2.1% | Are you a FirstBank customer? | Take the reader poll

There is something very different about Denver Startup Week this year. First, it’s now called Colorado Startup Week. The kickoff keynote is Tuesday, not Monday, when the five-day event starts. And it’s not just in downtown Denver anymore.

A Monday session on disruptive medical devices will be in Fort Collins. A health-tech pitch event Tuesday is in Boulder. A wellness break and a midafternoon happy hour are set for Thursday in Littleton.

And if you’d managed to get a spot for Friday’s 9 a.m. “Connect to Creativity Trailside” session (there’s a waitlist), the meet-up point is at the Mount Falcon Park trailhead in Jefferson County. From there, it’s a 1.5-mile hike to a scenic view for an outdoor painting class and, of course, networking with other founders.

“We’re very much not a sip and paint. We encourage folks to play with different colors, take risks and follow their creative flow,” said Sarah Leistico, who founded Abstract Adventures in 2023 to share her love of hiking and painting. “I think that passion for sharing the experience is what pushed me over the edge to be like, yes, I’m going to launch a company because I want to share this experience with others.”

Leistico has been volunteering and attending the weeklong entrepreneurial event since 2021, after moving to Denver from the Midwest. This year seemed like a great opportunity to be part of the newish “Community Events,” which are lightly vetted by organizers but rely on the energy and effort of the founder who pitched it to make it happen.

After all, Colorado Startup Week, much like its original Denver namesake, is run by volunteers. It’s still free and it’s still the scrappy gathering that has long relied on vacant or donated office spaces on or around 16th Street for panels, sessions and networking.

There will still be plenty of milling around downtown Denver, though. The event’s home base is 1900 Lawrence St. But the idea of letting folks organize their own events — and host them outside the city seemed inevitable.

“Previously, we’d have all these submissions but then every single session was curated and managed by the team, by our organizing committee of volunteers,” said Ben Deda, a cofounder of Denver Startup Week. “And some, unfortunately, wouldn’t get selected. As we evolved, we just saw an opportunity that there were a lot of people who wanted to do great stuff. Why should we be a barrier to that?”

Networking outside of Denver

Taylor Thomas and Christine Hernandez, founders of business consultancy Impact Initiative, hope attendees will make the 10-12 mile trek from downtown Denver to Littleton for a wellness break, networking and a happy hour.

They hosted sessions at past startup weeks focused on team building and communication, which flowed into a cocktail hour that was packed. This time, they wanted to provide a respite from the busy week at the coworking space they office at, Kiln Littleton.

“It’s kind of a break for the fast-paced nature of Startup Week,” Thomas said. “These are full days. And when you’re finished, you’re wiped. This is kind of an intentional reset and a chance for people to still get a ton of information, a ton of value and a ton of connections but in an intentionally different environment.”

There will be a cold plunge, sauna, happy hour and, should you so choose, a place to plug in and work. Attendees just have to get down to Littleton.

“The hope is that people will want to hang out and stay on site,” he said. “It does take a commitment to get there, but there’s also things to engage in so it’s not just idle time spent.”

Community sessions, which are in the second year, just needed to be “somehow related to innovation and entrepreneurship” with “no self-promotion,” according to event organizers.

It also helped make the event a little more manageable for volunteers like Deda, whose day job is CEO of Food Maven, which has AI-infused technology to help food service buyers make smart food purchases to minimize waste.

“And what we realized is we just saw differences in how people wanted to engage with big events,” Deda added, “and that we could do part of it even more decentralized than we had, and then still focus our efforts on a core set of sessions.”

The stats so far this year

Of the 230 sessions this year, 190 of them, or 83%, are community sessions. There’s still 40 sessions, including keynotes (like Jen Millet, president of the new Denver Summit FC women’s soccer team, and Denver Mayor Mike Johnston), managed by event organizers.

Overall, that’s a big drop compared with Startup Week’s pre-pandemic era. In 2019, sessions numbered 350. Registrations were closer to 20,000. COVID moved the event online, and it slowly trickled back in person since. Last year, roughly 12,000 people participated in 230 sessions, according to Downtown Denver Partnership, another long-time supporter.

Deda put the early registration count at “the high four figures.” But since registration is free and one can register anytime during the event, it’s tough to make a good estimate.

“We’ve been right around that for the last couple of years,” he said.

Expect an AI-infused week

The annual event has long been fueled by tech startups, the initial attendees during the first event in 2012 at a now-shuttered bar in downtown Denver.

Tech still rules in 2025. Top sponsors are Amazon and Caruso Ventures, the investment firm of Dan Caruso, a cofounder of telecom firms Zayo Group and Level 3 Communications (now part of Lumen Technologies). Connecting with investors and finding funding has also long been a draw of the show.

But more so than ever before, artificial intelligence has infused most sessions and panels. Approximately 172 of the 230 sessions have some tie-in with AI, Deda said. That’s 75%.

“Some of them are how do you actually use AI? How do you build on AI platforms? And how do you not get replaced by AI,” he said. “It’s the very technical to the very philosophical. But yeah, it’s not surprising with what we’re seeing going on in our world that AI is tied in some way to a lot of the sessions.”

Some of those AI sessions also feature the top local AI founders in the region, including Adeel Khan, whose AI startup MagicSchool, which aims to help teachers avoid burn out, raised $45 million from investors in February.

Another founder hosting a session is Nathan Sobo, whose Boulder company Zed Industries developed an open-source code editor to help humans collaborate with AI, raised $32 million from Silicon Valley’s Sequoia Capital last month.

“Something like that in Colorado, six or seven years ago, would not have been thought of that you’d have a company raising that amount from a firm like that,” Deda said. “And that’ll wrap with AI builders, which is (bringing) a bunch of AI startups that will provide demos to folks. That’s just one stage. If people want to go deep, they could show up at 10 o’clock (on Wednesday) and just get the fire hose until 7 p.m.”

While there will be sessions on integrating AI with jobs and employment, one thing missing this year is the annual job fair. It’s kind of a thorny topic for an industry where some employers get pretty excited about AI replacing human workers. But the U.S. and Colorado job market is currently in a labor lull so interest wasn’t there.

Also not really on the agenda: Dealing with Colorado’s upcoming AI law that will require companies to disclose when they’re using AI systems that could impact whether someone gets a job, apartment, loan or other consequential decision. The controversial law goes into effect June 30, unless opponents, which include many in the tech industry, persuade state lawmakers to change it in the next legislative session.

“There’s no specific event around that specific issue,” Deda said. “I would definitely say you’ll probably find that the vast majority of attendees probably lean one side versus the other on it. But there’s a number of sessions around AI and law, both from an IP standpoint (and) how you access data and what you do with it.”

AI panels are hard to miss and are found in every Colorado Startup Week track.

➔ More at Colorado Startup Week

Sun economy stories you may have missed

➔ A tiny chairlift in Leadville offers big opportunities for Colorado Mountain College and the ski resort industry. The hand-me-down platter lift from Steamboat will revive Leadville’s Dutch Henry ski area >> Read story

➔ The Colorado River Basin has operated in the red for most of the 21st century. Experts call for broad water cuts, now. >> Read story

➔ BLM counts on pent-up demand, offers more than 130,000 acres of public land in Colorado for oil and gas drilling. Planned lease auctions started Tuesday, with one of the largest offerings in more than 20 years that set a revenue record as the Trump administration reverses Biden-area slowdown. >> Read story

➔ How to treat a river: Reshaping the Arkansas River into a Colorado success after a century of abuse. From the high headwaters all the way to the state line, people who care are trying to redeem a hard-working stream. >> Read story

➔ Colorado awards Amazon $25.4 million to provide satellite internet to areas with poor service. Amazon also captured 44% of the state’s underserved locations. >> Read story

➔ Teachers, farmers and advocates urge Colorado voters to approve new funding for school meals and food stamps. The ballot initiatives LL and MM would shore up funding for the Healthy School Meals for All program and help cover the cost of federal cuts to SNAP. >> Read story

➔ EchoStar unloads wireless spectrum to Musk’s SpaceX for $17 billion. The Douglas County satellite company, which also operates Dish Network, is also selling off wireless spectrum to AT&T >> Read story

Take the reader poll: Feeling better or worse?

ICYMI: More than 200 folks have chimed in on how they’re feeling about the economy. If you haven’t already, take the current reader poll to help us better understand what Coloradans are feeling about the economy. Thanks in advance!

➔ Take the What’s Working reader poll: bit.ly/WWsept2025

Other working bits

➔ City of Colorado Springs faces $31 budget shortfall, cuts 38 jobs. It’s not just Denver. The state’s other large city said Friday that it’s trying to ward off the impact of a $31 million budget shortfall next year. That includes cuts to reduce the city’s workforce by 1%, or 38 jobs; and add at least five unpaid furlough days next year for all city workers, excluding those in public safety, critical operations and grant-funded positions.

The city also plans to reduce spending by $14.7 million among departments and its capital improvement program, permanently close the Meadows Park Community Center on Oct. 10 and forgo any cost of living or performance-based raises in 2026, according to a news release from the city.

➔ Consumer prices up 2.1% in Denver area. Does it seem like the cost of food and energy has declined since May? That’s what the data is showing for the Denver region, according to the change in the Consumer Price Index for July. But while the cost of food fell 0.7% and energy prices dropped 3.4% between May and July, overall prices were up from a year ago by 2.1%, according to the Bureau of Labor Statistics. Nationwide, inflation was up 2.7% from a year ago for July, and up 2.9% for August (Denver data is shared every other month, and most recently for July.)

The biggest Denver-area price increases for the past 12 months: eating out, up 4.3%; medical care, 6.4%; and items that are typically imported, like household furnishings, up 5% and apparel, up 4.9%. Gasoline saw the biggest drop, at 10%. >> See Denver data

➔ FirstBank acquired by PNC Bank for $4.1 billion. Colorado’s largest independent bank is getting gobbled up by Pittsburgh-based PNC in a deal that is expected to close in early 2026. The acquisition will make PNC the state’s largest bank, adding the Lakewood-based FirstBank’s 120 retail branches and $26.7 billion in assets >> Read story

• Was FirstBank your bank? Tell us your favorite memories or experiences with Colorado’s largest bank, at least currently. >> Email Tamara

➔ Fremont County gets its first Rural Jump-Start business. It took nine years but Fremont County finally got a business in the state’s initiative to support rural businesses that are growing and adding jobs. Mytikas Manufacturing, based in Florence, plans to add up to 170 new jobs to its business of building zero-waste tiny homes, according to the Office of Economic Development & International Trade, which oversees the Rural Jump-Start Program. The program provides state income tax relief and matching grants of up to $15,000. >> Details

Got some economic news or business bits Coloradans should know? Tell us: cosun.co/heyww

This week marked The Colorado Sun’s 7th anniversary. Thanks to all who’ve joined us since our start. If that’s you, forward this newsletter to a friend to keep What’s Working growing. Hang in there everyone! ~ tamara

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