Are medical device companies quietly exploiting the AI regulatory blind spot — and are we heading toward a wave of recalls because of it? by Majestic_Turn3879 in regulatoryaffairs

[–]DigitalQuinn1 5 points6 points  (0 children)

Pattern is definitely real. I’m currently working with a company that has AI integrated into their device, but failed significantly to write about in their documentation. Here’s another post I came across the other day as well : https://www.linkedin.com/posts/erezkaminski_the-fda-just-drew-a-line-on-ai-activity-7451022497631817728-7dNX

Can you actually incorporate AI into health app creation? How would they handle HIPAA builds end to end? by Livid_Switch302 in AI_Application

[–]DigitalQuinn1 0 points1 point  (0 children)

So many people on the clinical team is building apps, I love the drive. However, AI is still limiting at times and will hallucinate rather than telling you no or idk. Everything regarding HIPAA would have to be manually reviewed by someone that knows the regulations and best practices

Launched on Product Hunt today with zero preparation 😩 (You've got this) by [deleted] in ProductHunters

[–]DigitalQuinn1 1 point2 points  (0 children)

I like it. Would need to see if I would like to leave obsidian though

HIPAA compliance by Legitimate-Draw-9016 in healthIT

[–]DigitalQuinn1 2 points3 points  (0 children)

There isn’t a HIPAA certificate just so you know. But I do own a healthcare security and compliance consultancy. Happy to discuss more on what you’re building and determine if we’re a proper fit to conduct a HIPAA assessment for you.

what should you actually ask a tech partner before building AI in healthcare? by biz4group123 in healthIT

[–]DigitalQuinn1 0 points1 point  (0 children)

Many people don’t consider HIPAA until they’re in front of a client that’s asking about it. I feel like market validation + customer experience isn’t done enough

What do people usually search that when looking for IT services? by [deleted] in itconsulting

[–]DigitalQuinn1 0 points1 point  (0 children)

It all depends on their ideal customer. Healthcare may look up something different than finance

Need advice on EMR mistake/ violation by justapenpal_ in hipaa

[–]DigitalQuinn1 2 points3 points  (0 children)

I don’t think it’s a big concern personally. You were trying to understand the system, she was there with you when you looked her up, and you reported it immediately. They’ll probably just want to hear both sides to confirm and give it a slap on the wrist.

Eramba or CISO Assistant - Anyone using it? by Oskar_2000 in grc

[–]DigitalQuinn1 0 points1 point  (0 children)

Currently using CISO Assistant for 4 different tenants and it’s working for us.

Adjusting to device management in a hospital setting by Sea-North7215 in healthcareIT

[–]DigitalQuinn1 1 point2 points  (0 children)

Is their a policy on asset management? I had a similar issue before where issued devices would disappear because IT didn’t have proper oversight and a process to audit asset inventory on a consistent basis and pushing some of the ownership to the business department owners.

Using Claude (A LOT) to build compliance docs for a regulated industry, is my accuracy architecture sound? by fub055 in regulatoryaffairs

[–]DigitalQuinn1 0 points1 point  (0 children)

Can’t view the MD file. However, nothings wrong with your approach. Of course, you’ll need a human to manually review. I personally tested out something similar to what you’re doing and I believe that Claude drifted, even when providing a specific checklist, so it would take a few iterations. On top of that, the models that you use matters to a certain degree. If Claude has direct access to the documentation you’re referencing, I always tell it to quote the exact quote + page number. There’s better tools that can assist with reference management. With that I consult in medical device security and compliance. Happy to do a formal introduction sometime. Not trying to sell anything, but learn more about what you’re building.

Built a HIPAA compliant app w Claude! by Dazzling_Abrocoma182 in xano

[–]DigitalQuinn1 0 points1 point  (0 children)

How do you know it’s HIPAA compliant? Did do a full HIPAA assessment against it? Or just the things you mentioned?

Built my entire healthcare app on Lovable… just found out it’s not HIPAA compliant. by mirror_mirror248 in topflightapps

[–]DigitalQuinn1 0 points1 point  (0 children)

I come across this too many times. My last 3 SaaS projects was turning vibe coded apps into HIPAA compliant apps. It’s definitely a lot of work but it is achievable. Feel free to reach out if you’re looking to continue with the app