Digital Health

Digital health uses software and data to improve health and care delivery. It sits at the intersection of healthcare, technology and regulation. This creates specific design, evidence and compliance considerations for companies in this space.

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Navigating AI in Digital Health – Webinar

AI is transforming US healthcare, so what does that mean for NZ health tech startups.

Watch Fiona McPherson Grant discuss how major US providers adopt AI, what startups need to know about HIPAA and EMR integration, and how to align with market expectations.

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Digital health solutions operate in a regulated environment where software, data, and clinical functionality must meet defined standards.

Understanding these foundations early helps teams design safer products, plan evidence requirements, and avoid regulatory roadblocks.

Many digital products also enter clinical environments that rely on established electronic health records and hospital software systems. These systems influence how patient information is captured, shared, and accessed, and they define the workflows that new digital tools must fit into.

As companies move closer to real-world use, considerations such as interoperability, data-exchange standards, and workflow alignment become increasingly important. This page does not explore individual platforms or integration pathways in detail; it is included to provide high-level context for teams planning their broader digital health strategy.

The resources below introduce core areas relevant to most digital health companies:

  • General — global concepts and definitions in digital health, including Software as a Medical Device and key guidance shaping the sector.
  • Health system data — privacy, security, and data-governance requirements across New Zealand and major international markets.
  • Digital therapeutics and diagnostics — regulatory expectations for software that performs a medical purpose, such as diagnosis, monitoring, or therapeutic intervention.

Explore each section to understand what applies to your product and where to find further guidance.

Download our pdf guide

Digital health solutions operate in a regulated environment where software, data, and clinical functionality must meet defined standards.

Understanding these foundations early helps teams design safer products, plan evidence requirements, and avoid regulatory roadblocks. Many digital products also enter clinical environments that rely on established electronic health records and hospital software systems. These systems influence how patient information is captured, shared, and accessed, and they define the workflows that new digital tools must fit into.

As companies move closer to real-world use, considerations such as interoperability, data-exchange standards, and workflow alignment become increasingly important. This page does not explore individual platforms or integration pathways in detail; it is included to provide high-level context for teams planning their broader digital health strategy.

Explore each section to understand what applies to your product and where to find further guidance.

General

Global concepts and definitions in digital health, including Software as a Medical Device and key guidance shaping the sector.

Health system data

Privacy, security, and data-governance requirements across New Zealand and major international markets.

Digital therapeutics and diagnostics

Regulatory expectations for software that performs a medical purpose, such as diagnosis, monitoring, or therapeutic intervention.

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Use this section to understand the core concepts that underpin digital health, including common definitions, how software becomes a regulated medical device, and where ethical guidance is evolving.

Use this section when designing products that handle health information — it outlines privacy, security and data-handling requirements across major markets.
Use this section to understand when software is considered a regulated medical device, how different markets classify digital therapeutics (DTx) and diagnostic software, and where to find category-specific guidance.

Connecting to the Digital Health Ecosystem

Find out more

Understanding the digital health landscape involves learning how solutions fit into clinical workflows, data environments, and regulatory settings. Explore the resources below to support your journey.

Latest Resources