
Loading summary
Unknown Speaker
Foreign.
Ed Gaudet
Welcome to Risk Never Sleeps, where we meet and get to know the people delivering patient care and protecting patient safety. I'm your host, Ed Gaudet.
Saul
Hello, everyone and welcome back to the AI Med Podcast, the insight series of the podcast brought to you by Sentinet and also Outcomes Rocket. I'm here with my co host, Ed Gaudette.
Ed Gaudette
Hey, Saul.
Saul
What's up, Ed?
Ed Gaudette
How are you?
Saul
It's been great.
Ed Gaudette
It's been. Yeah. Fun.
Saul
And it's about to get better.
Ed Gaudette
It's gonna get so much better because.
Saul
We are with Anna E. Santiago. She is the CISO at Christiana Care. Anna E. Welcome.
Anna E. Santiago
Thanks for having me.
Saul
It's such a pleasure. Ed, talk to us.
Ed Gaudette
So that was fun on the panel. What'd you think?
Anna E. Santiago
I thought it went by too quickly.
Ed Gaudette
It did. I thought we had to talk about more time too.
Anna E. Santiago
Did she.
Ed Gaudette
Was it like an audible called at the end that? Like, did we have different questions or.
Anna E. Santiago
I. Yes, she definitely called an audible and she said it. She said she was going to go script and she did. I think it's better when.
Ed Gaudette
Fine. I like it.
Anna E. Santiago
I prefer that.
Saul
Me too.
Ed Gaudette
Me too. Yeah.
Anna E. Santiago
Yeah.
Ed Gaudette
I don't like panels that are scripted or where they try to box me. That'll do well in a box.
Saul
I definitely know that. I'm taking notes. Oh, you.
Ed Gaudette
Oh, that's good.
Saul
That's good.
Ed Gaudette
Ani, what's the most interesting thing you've learned so far?
Anna E. Santiago
None of that. I've learned this, but affirmed that there's a lot of exciting things that can happen in healthcare through the use of AI and that the impact that it can have on care delivery is monumental, transformative.
Ed Gaudette
Truly is. Now you're doing a lot at Christiana Care.
Anna E. Santiago
We are. Yeah, we are. We're a technology forward organization that wants to be the first to do everything. And so we're herding the cats, standing up our governance processes and ensuring that we are building the appropriate guardrails to do it effectively. But certainly that train has left the building.
Ed Gaudette
Do you have anything deployed that ambient listening or.
Anna E. Santiago
We have ambient listening. We have some AI in the rest cycle space as well as the scheduling space. And of course, we've got traditional AI in our cybersecurity products that we've been running for over a decade. So we're all in.
Ed Gaudette
They're all in. What are you doing? You. Your process? Are you bringing it into like a sandbox area first to test?
Anna E. Santiago
And so we have. So we've stood up an AI governance process and have developed a rubric a risk management rubric. And so any new projects that we want to bring through. Through for assessment goes into that rubric, which includes your typical questionnaire, among other things, that is reviewed by our governance team, and then depending on the complexity, might be moved over to our innovation and engineering team, who does the testing and the assessment for tech efficacy.
Unknown Speaker
Got it?
Ed Gaudette
Got it. What's the biggest challenge been with adopting AI?
Anna E. Santiago
So, a couple of things. The velocity at which people want to adopt it and the lack of understanding exactly of what the risks are. I think people generally understand the cybersecurity risks, yet we all know that there's clinical risk, there's ethical bias, there's so many different things. And so helping our organization to really be educated and ensure that they're aligning what we want to do with the policy that has been established is certainly one. I would say that another risk is we don't know what we don't know. Right. This is a really new technology, and although some of us claim to be a little bit more experts than others, we're not experts.
Ed Gaudette
Right.
Anna E. Santiago
I don't know what I don't know. And so I've had to become very comfortable in acknowledging that I don't know what I don't know. And that has to be an acceptable answer. But collectively we can make the appropriate decisions. Even just as morning we were meeting, our governance committee was meeting and somebody asked the question, who owns the risk? And frankly, I chimed in such a great question. Yeah, no one collect, no one person can own the risk. The steer can help to manage and communicate the risk, but the steer doesn't own it and no one member in the steer owns it as well. And so I think in cybersecurity, we've done a pretty good job of understanding governance frameworks because we've been doing it for so long. And now helping other steers, like the AI governance steer to understand what risk management frameworks look like and how they work has been a little bit of an uphill battle. Yeah, I shouldn't say battle, but it's been work.
Ed Gaudette
We're all bringing different functions together that have different levels of understanding and then facilitating that. Who runs the stair for you?
Anna E. Santiago
So it used to be the head of our innovation center, and she has since left. So yours truly.
Ed Gaudette
Oh, there it is.
Anna E. Santiago
Was tapped.
Ed Gaudette
Grand Wizard AI governance right there.
Anna E. Santiago
So I'm helping to advance, but it really, you know, I've really pushed that. Every voice has to be equally loud and acknowledged in this work. It's not just a cyber security Issue.
Ed Gaudette
How often do you meet?
Anna E. Santiago
We currently meet monthly, but now we've agreed to meet weekly.
Unknown Speaker
Weekly?
Anna E. Santiago
Yeah. There's just so much. There's just so much activity right now. I think we have 10 different technologies that have been introduced for assessment. And the one thing that we know is we can't be the ones to slow things down. Like, we just. We don't live in a culture where we move slowly.
Ed Gaudette
So you're guiding folks as they're bringing in new things. Are you guiding them and say, okay, what's your use case? And let's start by defining that first and.
Anna E. Santiago
Exactly. Exactly. And does it fit within our rubric? We have. We've always had this methodology of if we've got platforms that do it today or those. It's in their roadmap. You're going to have to make a really good case for why you wouldn't use those platforms. And we are trying to fit that framework into now all of the AI.
Ed Gaudette
Use cases don't bring me a new AI ticketing system if I use ServiceNow. And ServiceNow can do the job right. All right, Saul.
Saul
Yeah, no, it's. It's fascinating. It's moving fast. And on the networking side of being here, have you met any interesting people?
Anna E. Santiago
I have not, unfortunately. As I mentioned, I've spent quite a bit of time in my hotel room trying to juggle all of the different balls that was juggle on any given day.
Ed Gaudette
So it's so hard to travel, isn't it?
Anna E. Santiago
It's hard because I still have a full time that I need to get done and people don't want to wait because I'm traveling.
Ed Gaudette
Everybody needs something.
Anna E. Santiago
Absolutely. And I get the luxury to travel, so I need to do my part to ensure that I'm present with work as well.
Saul
Is there any AI that could help you with what you do? Free you up? Well, can it free you up?
Anna E. Santiago
I will be very honest.
Ed Gaudette
A digital twin.
Saul
Oh, how about that?
Anna E. Santiago
That would be fabulous.
Ed Gaudette
That could help schedule time and manage your administrative tasks. That would be great.
Anna E. Santiago
I would love that.
Unknown Speaker
Me too.
Anna E. Santiago
But honestly, Copilot has become a crutch for me, really. I no longer just do things from scratch. I asked Copilot to get something started and then I refined. That's it saved me a lot of times. And we also have some members in our organization that enjoyed the written word. So getting Copilot to just summarize the email so that I can move on.
Saul
To the next really helpful word. Long emails. Yeah, we call them brick walls.
Ed Gaudette
Yeah.
Anna E. Santiago
Well, and honestly, in the security space, for sure.
Saul
Yeah.
Anna E. Santiago
We have to move fast and the AI is going to help us.
Ed Gaudette
If I have to page down in an email, I'm not going to page down.
Saul
It's a bad move.
Ed Gaudette
Yeah, it's a bad move. Put in a document if I got to read more than a. Right.
Saul
Yeah. That's not what email's for. No.
Anna E. Santiago
But emails become the tool for everything that it was never meant to be.
Saul
Yeah, you're right about that. Are you going to do anything different as a result of being here when you go back?
Anna E. Santiago
I'm certainly going to bring back some of the learnings and the sharings that I've walked away with, frankly, in addition to what's happening here, the Healthcare Sector Coordinating Council just issued an announcement about the AI products that they're going to bring forth. That's actually. I'm very excited about that. So I feel like I have a pretty good amount of work to put forth when I get back.
Saul
It doesn't stop.
Anna E. Santiago
It never stops.
Saul
But you love it.
Anna E. Santiago
That's why I'm a ciso.
Ed Gaudette
You do. You have to love that job to do that job.
Anna E. Santiago
You have to love the job and you have to love learning and you have to love doing new things over and over again. And that's exciting for me.
Ed Gaudette
Yeah. And you've been there how long, though?
Anna E. Santiago
Ten and a half years. I know.
Ed Gaudette
That's incredible though. That's incredible.
Saul
How long you been in the Cicero?
Anna E. Santiago
So I was hired into the Cicero. Oh, okay. Okay.
Saul
So you've been doing the Cicero for 10 years.
Anna E. Santiago
Yeah. So I started at Einstein Healthcare Network in 05 as our very first information security officer.
Unknown Speaker
Cool.
Anna E. Santiago
I then adopted the privacy officer role and I did that for ten and a half years before moving to Christiana and now another ten and a half at Christiana. So something is either right or wrong with me.
Ed Gaudette
Yeah, you're the decade ciso.
Saul
I love that.
Ed Gaudette
Yeah.
Saul
That's rare, right?
Ed Gaudette
There are many CISOs that have lasted more than five years, let alone.
Saul
Is that the average tenure, five years?
Ed Gaudette
No, it's like 18 months or something like that.
Unknown Speaker
Yeah.
Ed Gaudette
It's insane.
Saul
Well, you're a very reliable ciso.
Anna E. Santiago
I'm also lucky that I work.
Ed Gaudette
She's damn good in her job there. Reliable. What is that?
Saul
And damn good. I guess both.
Anna E. Santiago
Knock on wood. But I just have worked for two really special, wonderful organizations and there's absolutely. Christianicare has given me absolutely no reason to want to go anywhere else.
Ed Gaudette
And congratulations. You just won an award recently. Right.
Anna E. Santiago
I did see so.
Ed Gaudette
Of the year.
Anna E. Santiago
Global cso.
Saul
Damn. Of the globe of the year for the year.
Ed Gaudette
No. Who's that? CISO magazine.
Anna E. Santiago
Or was it Cyber Defense?
Saul
Cyber Defense.
Ed Gaudette
Cyber Defense Magazine.
Anna E. Santiago
Wow.
Ed Gaudette
Yeah. It's incredible, huh?
Saul
How does it feel?
Anna E. Santiago
It just feels good to be recognized for giving back to industry that I'm super passionate about. But honestly, even without the recognition, just knowing that every day we're impacting patients and healthcare positively is all that I need.
Ed Gaudette
Cyber safety is patient safety, as we say in the hsc.
Saul
That is correct. I love Greg Garcia. He's awesome.
Ed Gaudette
He is.
Saul
Shout out to him.
Ed Gaudette
We're going to see him next week, right?
Anna E. Santiago
Yeah, we are.
Ed Gaudette
Yeah.
Anna E. Santiago
Yeah.
Ed Gaudette
St. Louis.
Anna E. Santiago
All hands meeting.
Unknown Speaker
All hands.
Ed Gaudette
We're on the road again, so.
Saul
Great. Well, and I know you've been on Ed's podcast before and has he. Has. Have you asked her the lightning round questions?
Ed Gaudette
I have probably. I haven't asked her this question, though. If you go back in time and change one decision you made, what would it be? I know, it's a new one.
Anna E. Santiago
That's interesting. Yeah, I would. I don't even have a good answer for that. You've stumped me. Oh, no, I've never been stumped before.
Ed Gaudette
Someone said today when they were younger, their mother made them put milk in a microwave and then drink it.
Unknown Speaker
That was.
Ed Gaudette
She said, I won't. I would never drink the milk again. Were you here?
Saul
I missed that one. I wasn't there.
Ed Gaudette
Okay. Okay. Yeah, that was. Was that Nick? Nick Lynn? Yeah. That was an incredible answer. So it could be any decision. It doesn't have to be anything like.
Anna E. Santiago
Yeah. So I've always lived, and I'm just oversharing. Just lived a life of no regret because I feel like every decision that I've made, whether it was good or bad, led to my growth. And perhaps a decision that I would make differently is early on in my career when I was still learning to be a leader, I would just put people in roles and just assume that they were happy in their role. And I had one individual that resigned. And when he gave his exit interview, I had learned that it was because he wanted to do offensive cybersecurity. And we outsourced that. And so I changed my approach to being a leader to ensure that I'm always asking people and being intentional about ensuring that they are not just fulfilling their existing role, but growing.
Ed Gaudette
Yeah.
Anna E. Santiago
So would I do it differently? I learned.
Ed Gaudette
You learned from it. Yeah. Yeah, yeah. No, I love that answer. It's hard, especially if you've led a life with no regrets.
Unknown Speaker
Right.
Ed Gaudette
And because there's that butterfly effect.
Anna E. Santiago
Right.
Ed Gaudette
If I make that decision differently, what would that have caused and rippled.
Unknown Speaker
Right.
Ed Gaudette
Who knows?
Unknown Speaker
Right.
Anna E. Santiago
Exactly.
Ed Gaudette
Maybe you wouldn't be here today.
Anna E. Santiago
You never, honestly never know.
Ed Gaudette
You don't know.
Saul
I love that one. On our company, we do the PPF process. It's personal, professional, financial. And we talk one, one, two, and three years from now. Where do you want to be? What do you want to do? Personal, professional, financial. And that one thing that we've done at our business has really helped just connect. Personal mission, business mission.
Anna E. Santiago
Love that.
Ed Gaudette
Yeah, me too.
Saul
And it's been really effective for us. The team loves it.
Ed Gaudette
What do people typically say for financial.
Saul
Well, they want to make more money. How much they want to make. They want to get out of debt. That was one. And coaching them to. To work through that. And so just it ranges. Right. Like, I want to learn how to invest more.
Ed Gaudette
Yeah.
Saul
Interesting. I want to buy houses.
Ed Gaudette
Yeah. Nice.
Saul
I want to buy my first place. Like, these are the things. And then you get granular with them about how you save money. How much do you want? What kind of place? Like, literally, I was having a conversation. It's really good. Okay, you want a place, but tell me more about the place. So we got to seventh floor, facing the water, two bedroom, one and a half bath. Now we're talking. Right? And what. Where do you want to buy it? What's the price range? So then they.
Ed Gaudette
They had a plan.
Saul
Yeah.
Ed Gaudette
You gave them a plan.
Saul
It was great.
Ed Gaudette
I love that.
Anna E. Santiago
That's so cool. I might borrow that.
Saul
I'll send you the template if you want.
Anna E. Santiago
I would love it. Thank you.
Saul
It's part of our pretty cool engagement and retention process.
Anna E. Santiago
So I'm excited. That might be the biggest takeaway through this conference.
Saul
You're too kind.
Anna E. Santiago
I'm serious.
Saul
You're too kind. Anai. I love that.
Ed Gaudette
Where are you going next for. You were in Australia for a while.
Anna E. Santiago
I was in Australia, Yeah. I just got back a couple weeks ago.
Ed Gaudette
Yeah, I know. How was that trip?
Anna E. Santiago
That was incredible.
Ed Gaudette
Do you see any big spiders?
Anna E. Santiago
I did not see anything that I thought could kill me. Oh.
Ed Gaudette
Because they have weird stuff there.
Anna E. Santiago
Apparently. It's the country where they have the most things that can kill you.
Ed Gaudette
Yeah, that's right. Oh, you didn't see anything that could kill you.
Anna E. Santiago
I saw alligators or crocodiles, but not in the wild. Like, at, like, animal sanctuaries.
Ed Gaudette
Kangaroos can kill you too. Like, they could hit you. Yeah, they're nasty.
Anna E. Santiago
Allegedly. But I fed kangaroos and they were super adorable.
Ed Gaudette
They might be medicated kangaroos. Mangaroos.
Anna E. Santiago
What I learned is that koalas, apparently they spend most of the day sleeping, but when they are awake, they are essentially drugged from the eucalyptus plant. So they live their lives either sleeping or on drugs.
Ed Gaudette
Story of my college career right there. I was sleeping or on drugs. I'm a koala bear. It's amazing. I graduated now. Oh, Mark's not laughing. There's heart. Get in here. We're going to talk sports next. Oh, forever. Come on. Come on. Mark, you can ask Ani a question.
Saul
I did.
Unknown Speaker
We had dinner.
Ed Gaudette
I know.
Unknown Speaker
And we talked a lot. Asked a lot of questions. So. Yeah. I would say my biggest takeaway is if there was any Philly fan I wanted to have dinner again with, it would be Anahi. I'm a Cowboys fan and I'm not really big into Philly, but my wife's cousin's from Philly, so.
Ed Gaudette
Yeah.
Unknown Speaker
Yeah.
Ed Gaudette
Philly fans are passionate.
Saul
Yeah.
Ed Gaudette
Yeah. Like Boston fans. Right. Only you're a little crazier.
Anna E. Santiago
We're a little unhinged.
Ed Gaudette
Yeah. I think a little more.
Anna E. Santiago
But we wear it.
Ed Gaudette
You're closer to the New York fans than you are the Boston fans.
Anna E. Santiago
I think we've probably surpassed the probably fans I was.
Ed Gaudette
Yeah.
Anna E. Santiago
But we own it.
Ed Gaudette
You don't want to be in a.
Unknown Speaker
Philly bar if they're losing stadium.
Anna E. Santiago
What do I miss the old stadium? Absolutely not.
Unknown Speaker
The concrete.
Anna E. Santiago
Yeah. No, my seat didn't work. I had to actually climb on top of my seat. Like, my seat wouldn't go up.
Ed Gaudette
So that's why they're angry.
Anna E. Santiago
Yeah. I literally had to stand up on my seat so people could walk in front of me.
Unknown Speaker
What?
Anna E. Santiago
That place was such a dump.
Ed Gaudette
What a. Yeah.
Saul
God is done, right?
Ed Gaudette
It's like the Boston Garden. I could never understand that. Boston Garden was awful. Like, why would you want to preserve the Boston Garden?
Unknown Speaker
You know what happened in the last game of the stadium?
Anna E. Santiago
Tampa Bay. Oh, my God. You just saw.
Ed Gaudette
You just took the life out of her.
Anna E. Santiago
Mark. Yeah.
Ed Gaudette
What the hell?
Anna E. Santiago
That. That to this day is the worst night that I can sports wise.
Ed Gaudette
Really?
Anna E. Santiago
The worst night I just. I remember walking back to. So it was for the listeners. The Eagles played Tampa Bay in the championship game. And at the time, there was a stat that Tampa Bay had never won a game in under 40 degree weather. And it was freezing.
Ed Gaudette
Oh.
Anna E. Santiago
Like we tailgated in a U Haul truck. We actually rented a U Haul truck. That's awesome. And put heaters inside.
Ed Gaudette
You probably had a fire going in that truck.
Anna E. Santiago
Well, so we had heaters in the trunk and then we fried our turkey.
Unknown Speaker
And it was in the truck.
Saul
Oh, thank God.
Ed Gaudette
That's dangerous. That's the riskiest thing.
Anna E. Santiago
We were so confident.
Ed Gaudette
Yeah.
Anna E. Santiago
And we got.
Ed Gaudette
Yeah, you were having Thanksgiving dinner.
Anna E. Santiago
I'm like, yeah, it was. And I still remember the walk back to the U Haul truck. And it was just quiet. So silent. Like this eerie quietness. And then every once in a while you would hear an S bomb and then it would get quiet again. And it was just. It felt like the longest walk in 20 degree weather back to our car.
Ed Gaudette
Like coming out of the movie Blue Velvet for the first time. It was very quiet. People are like, what did I just watch?
Anna E. Santiago
Never saw that.
Ed Gaudette
Oh, don't watch it.
Saul
I haven't watched it either. It's so weird, right?
Ed Gaudette
David lynch movie. All right. All right, Mark, another question to really bring the tone down, the demeanor down.
Anna E. Santiago
Oh, he's thinking.
Ed Gaudette
He's thinking. Yeah.
Unknown Speaker
Favorite Philadelphia sports moment.
Anna E. Santiago
Wow. Most likely the Minnesota Super Bowl LII Just being in the building and watching our team win their very first super bowl ever in history was incredible. Incredible experience.
Unknown Speaker
Philly special, right?
Anna E. Santiago
That was the Philly special during that game.
Ed Gaudette
What's the Philly special, Mark?
Unknown Speaker
That's with. Was it Nick Foles?
Anna E. Santiago
So Nick Foles was our quarterback and he essentially caught the ball from one of our tight ends in a trick play.
Ed Gaudette
Oh, I love the trick play.
Unknown Speaker
Wasn't Brent Selleck, was it? Was it, Brent?
Anna E. Santiago
It was not Bren Selleck. It was our third string.
Ed Gaudette
Really?
Anna E. Santiago
Yeah, he was our third string tight end.
Ed Gaudette
They throw the third stringer out there for the trick play. That's tricky. That's tricky as hell. Cause no one's expecting that.
Anna E. Santiago
Right? No one's expecting that.
Ed Gaudette
Who's this guy coming out?
Anna E. Santiago
Well, the interesting thing is earlier in the game, the Patriots had tried to throw the ball to Brady and of course he dropped it. But of course, of course he did.
Ed Gaudette
Oh, that's painful.
Anna E. Santiago
I had a little.
Ed Gaudette
Yeah, that was good. Well done. Well done. Yeah. How many rings do we have? I'm sorry. Six? Seven.
Unknown Speaker
Given the two, I would choose Philadelphia over New England.
Ed Gaudette
Everybody hates New England. You know why haters gonna hate?
Unknown Speaker
Because. Sorry. Because.
Ed Gaudette
Shake it off because they cheat. Shake it off because they Taylor footballs. You're a Cowboys fan, okay. You're always in misery.
Saul
Yeah.
Ed Gaudette
And the Jess fan, too. Originally a Jets fan.
Unknown Speaker
No.
Ed Gaudette
That's the worst, isn't it?
Anna E. Santiago
That's what were you?
Ed Gaudette
That's the worst.
Unknown Speaker
What were you originally?
Ed Gaudette
I was a Raiders fan of his.
Unknown Speaker
See?
Anna E. Santiago
What is that?
Unknown Speaker
I don't know.
Ed Gaudette
Howie Long. Come on. Layla Zado. Oh, my God. Stabler. Kenny Stabler.
Unknown Speaker
Come on the mat.
Ed Gaudette
John Matac.
Anna E. Santiago
Oh, I know.
Ed Gaudette
Great guy.
Anna E. Santiago
You had me at Howe Long because he was. Because he burged. Chris Long.
Ed Gaudette
Yeah.
Anna E. Santiago
Obsessed with him.
Unknown Speaker
Really?
Ed Gaudette
I think everybody in this panel is obsessed.
Unknown Speaker
Coming on the podcast.
Ed Gaudette
Yeah.
Anna E. Santiago
What? Yeah, like, I want that one.
Saul
That was good.
Ed Gaudette
That was good. Wow, Mark, Funny zinger from. And we're here with Mark Gaudette and his first joke ever.
Saul
We love to give all of our guests sort of an opportunity to share where your work could be found and where could they learn more about you. So where can our listeners do that?
Anna E. Santiago
Gosh, I'm all over LinkedIn. Okay, so follow me on LinkedIn Connect. Don't try to sell me things.
Ed Gaudette
Don't sell her, please.
Anna E. Santiago
I become a not so nice person when you try and sell me things, but certainly I love sharing thought leadership there. That's probably where I share the most. Awesome. So connect with me.
Saul
That's fantastic. We'll leave that in the show notes so you guys can get in touch with Anai Santiago Ciso at ChristianaCare. Thank you all for tuning in. And, Anai, thanks for joining us.
Ed Gaudette
Yeah, thank you.
Anna E. Santiago
Thanks for having me. This was fun.
Ed Gaudette
All right.
Ed Gaudet
Thanks for listening to Risk Never Sleeps. For the show notes, resources and more information and how to transform the protection of patient safety, Visit us@SenseInet.com that's C-E N S I N E T dot com. I'm your host, Ed Gaudet. And until next time, stay vigilant because Risk never Sleeps.
Guest: Anahi Santiago, Chief Information Security Officer at ChristianaCare
Host: Ed Gaudet
Date: December 22, 2025
In this episode, Ed Gaudet sits down with Anahi Santiago, CISO at ChristianaCare, to delve into the challenges and opportunities presented by AI adoption in healthcare. The discussion centers on AI governance, risk management, and the importance of humility and collective leadership in a rapidly evolving technological landscape. Santiago shares firsthand experiences from her organization's journey to implement and oversee AI while safeguarding patient safety.
This episode delivers deep, candid insights into the realities of AI adoption in health systems. Anahi Santiago exemplifies thoughtful, humble leadership—prioritizing collective governance, acknowledging the unknowns in AI risk, and promoting continuous professional and personal growth. Listeners gain both strategic and practical takeaways for advancing patient safety and responsible innovation in a complex digital health landscape.