# Auditdata Brings Internationally Certified AI Governance to Hearing Care

> AI is now embedded in how software is built, delivered, and improved, including the tools hearing care professionals rely on every day. As AI adoption accelerates across the technology industry, a critical question emerges for healthcare organizations: how do you know if your software vendor governs AI responsibly?

**Author:** Emma Rytter Skovgaard
**Published:** 2026-04-27

AI is now embedded in how software is built, delivered, and improved, including the tools hearing care professionals rely on every day. As AI adoption accelerates across the technology industry, a critical question emerges for healthcare organizations: how do you know if your software vendor governs AI responsibly?

![Auditdata and ai news.png](https://www.auditdata.com/media/bk4jx25u/auditdata-and-ai-news.png)

Governing How AI is Used Across Software Development, Operations, & Service Delivery

Auditdata, a global provider of [practice management management software](https://www.auditdata.com/ "Auditdata.com") for hearing care, today announced it has achieved [ISO/IEC 42001:2023](https://www.auditdata.com/media/e0tdiwmb/auditdata_42001_enf49_45100057_web_v1_08c91417-1cec-4a04-84b8-704db6c2dafc_en-16.pdf "Auditdata_42001_ENF49_45100057_web_v1_08c91417-1cec-4a04-84b8-704db6c2dafc_en[16].pdf") certification, the international standard for AI management systems, providing independently verified assurance that its use of AI is governed responsibly. The certification covers AI use across software development, operations, consulting services, and internal processes.

Following the third-party audit, the certified management system establishes commitments to responsible and transparent use of AI outputs with human review, privacy and safety protection, GDPR compliance, third-party AI risk management, and human oversight of AI-assisted processes. This certification is integrated with Auditdata’s existing management systems (ISO 27001, ISO 13485, EU MDR), maintained for over a decade. [**Learn more**](https://www.auditdata.com/company/compliance/iso-42001-certified-ai-governance/ "ISO 42001 Certified AI Governance ")

The risks of ungoverned AI in healthcare software are concrete; patient data exposed to third-party AI systems without consent or audit trail, AI-generated outputs influencing clinical decisions without human verification, bias in training data producing uneven care across patient populations, and regulatory liability under the EU AI Act and GDPR cascading from vendor to clinic. ISO/IEC 42001 addresses each of these directly, every AI system in scope is identified, risk-assessed, monitored, and governed by documented, externally audited controls rather than internal policy alone.

Most software company now uses AI, in development, operations, and across the business. Hearing care professionals around the world depend on Auditdata’s tools, and they deserve to know that we govern that use responsibly. The ISO 42001 certification is our way of proving it. 

Every AI tool we use, every AI-assisted process, is subject to human oversight, structured risk management, and independent audit. We've applied that standard of accountability to information security and medical device quality for over a decade. Extending it to AI was never optional for us, it was the obvious next step.

Kurt Bager, CEO

![Kurt Bager](https://www.auditdata.com/media/ytxdflud/kurt-bager.jpg)

Auditdata

Hearing care is one of the fastest-adopting healthcare sectors for AI. Denmark, Auditdata’s headquarter location, leads the European Union with a [27.6% enterprise AI adoption rate](https://ec.europa.eu/eurostat/web/products-eurostat-news/w/ddn-20250123-3#:~:text=In%202024%2C%2013.5%25%20of%20enterprises,and%20Spain%20%28+2.1%20pp%29.&amp;text=Enterprises%20continued%20to%20adopt%20various,%25%20enterprises%20%28+2.2%20pp%29. "ec.europa.eu"). Clinics, hospitals, and hearing care organizations need assurance that the AI their vendors use is governed to a stringent healthcare-grade standard. Now, ISO 42001 provides that assurance, with an independently audited, not self-declared, certification.

With the upcoming EU AI Act, enforceable in August 2026, AI governance will become a regulatory requirement. Auditdata has already implemented aligned controls. With a decade of healthcare compliance already behind it, AI governance isn’t bolted on, it's woven into how Auditdata designs, builds, and maintains its products.

ISO/IEC 42001, published in December 2023, is the first international standard for AI management systems. Fewer than 50 organizations worldwide currently hold the certification, including major technology companies. Auditdata is the first patient management system vendor globally to join this group.

This certified framework will govern all future AI initiatives across Auditdata’s operations and the processes supporting its products.. Annual surveillance audits will ensure that governance keeps pace with technology. The governance focuses, and will continue to focus, on responsible and transparent use of AI outputs, empowering hearing care professionals using Auditdata’s solutions to provide the Best Care Experiences to every patient.

Clinics working with Auditdata can feel confident that they have a vendor that's ahead of the compliance curve—not scrambling to catch up,” Bager continued. "When the company building your hearing care software governs every use of AI, from development to delivery, under an internationally audited standard, that's a different kind of vendor. And that’s what Auditdata delivers.

Kurt Bager, CEO

![Kurt Bager](https://www.auditdata.com/media/ytxdflud/kurt-bager.jpg)

Auditdata

## **About Auditdata**

Auditdata is a global provider of patient management systems for hearing care. The company's solutions support the full patient journey—from screening and audiological assessment to fitting, practice management, and aftercare — helping hearing care professionals deliver the Best Care Experience. Auditdata enables hearing care professionals, clinics, and hospitals to dispense the best care for their patients through data-driven software, hardware, and services that improve operational efficiency and enrich the patient-provider relationship.  Our team of dedicated professionals spans the globe, with employees in Europe, the United States, Canada, Australia, New Zealand, and more.

Since 1992, Auditdata has connected the customer journey and provided professionals with the tools and insights needed to enhance treatment at every touchpoint. Whether elevating accuracy in clinical testing or empowering better conversations with patients, Auditdata solutions enable the knowledge and compassion that make the difference across the pre-clinic, in-clinic, and aftercare journey.

More than 430 million people deal with hearing impairment, yet only 20% of affected individuals wear hearing aids. Auditdata aims to close the gap of untreated hearing disabilities by working closely together with hearing care professionals worldwide to improve the care experience for everyone facing hearing impairment—from early detection to aftercare.

### **Media Contacts**

#### Emma Rytter Skovgaard

#### VP of Marketing

#### http://Auditdata.com

#### emma@auditdata.com
