Health-tech sits right at the collision point of two of the hardest areas in patent law: software patentability and medical exclusions. A health app or wearable often needs to clear both hurdles proving it’s more than “just software” and proving it’s more than “just a diagnostic method” before a patent office will grant it protection.
This post covers what’s patentable in health-tech, why software and medical exclusions both apply here, where innovation is concentrated, and how PATHtoIP fits into the process.
What Makes a Health-Technology Invention Patentable
The Three Basic Tests
Standard novelty, inventive step, and industrial applicability tests apply but health-tech claims also need to survive software-related exclusions (Section 3(k) in India) and medical method exclusions (Section 3(i) in India) simultaneously.
What Typically Gets Filed
- Wearable device hardware and sensors
- Health-monitoring algorithms tied to a specific technical improvement
- Software platforms for remote patient monitoring or telehealth
- Data processing methods for interpreting biometric signals
Search and Freedom to Operate
Patentability Search
Needs to cover both software patent literature and medical device prior art, since health-tech inventions frequently sit across both categories.
Freedom to Operate
Particularly relevant for wearables, since foundational sensor and signal-processing patents are often held by a small number of large device makers.
India vs. the US: A Quick Comparison
| India | United States | |
| Governing law | Patents Act, 1970 | 35 U.S.C. (Patent Act) |
| Software-based claims | Excluded under Section 3(k) unless tied to a technical effect or hardware improvement | Assessed under the Alice/Mayo two-step framework for abstract ideas |
| Diagnostic algorithms | Face Section 3(i) and 3(k) scrutiny together | Face heightened scrutiny post-Mayo, especially for algorithms based on natural correlations |
| Data privacy overlay | Governed separately under India’s data protection framework | Governed separately under HIPAA and state-level laws |
Health-tech claims in India often need to clear two exclusions at once Section 3(k) for the software component and Section 3(i) if any part of the claim touches diagnosis. The practical fix is usually to frame the claim around a specific technical improvement (like sensor accuracy or processing efficiency) rather than the diagnostic outcome itself. The US applies a similar logic through the Alice/Mayo framework, which asks whether a claim is directed to an abstract idea and, if so, whether it adds “significantly more.”
Where Innovation Is Actually Happening
Continuous Health Monitoring
Wearables tracking heart rhythm, blood oxygen, or glucose levels in real time, Apple Watch’s ECG feature is a well-known example of a wearable capability that required its own patent and regulatory clearance path.
AI-assisted Diagnostics
Software analyzing patient data or imaging to flag potential conditions for clinician review.
Telehealth Platforms
Remote consultation and monitoring infrastructure, with IP concentrated more in platform architecture and workflow than in any single “big idea.”
Digital Therapeutics
Software-based interventions designed to treat or manage a condition directly, a newer category still being shaped by regulators and patent offices alike.
Protecting the Product from Every Angle
Patents
Cover a specific technical improvement like a novel sensor design or signal-processing method rather than the general concept of monitoring a health metric.
Trademarks
Brand trust matters heavily in health-tech, where users are choosing a platform to handle sensitive personal health data.
Trade Secrets
Backend algorithms for interpreting biometric data are frequently kept as trade secrets, since they can be refined continuously without being locked into what was disclosed in a patent application.
Copyright
The underlying software code is separately protected by copyright, independent of any patent covering the broader system or method.
How PATHtoIP Helps
- Patentability searches spanning both software and medical device prior art
- Freedom to Operate analysis, especially relevant for wearables built on licensed sensor technology
- Patent drafting and filing framed around technical improvements to clear Section 3(k) and 3(i) scrutiny in India
- Trademark filing to build user trust in a crowded health-tech market
- Technology landscape analysis to identify white space before committing engineering resources to a monitoring or diagnostic feature
Frequently Asked Questions
Can a health app or algorithm be patented in India?
It’s difficult if the claim is framed purely as software or as a diagnostic method both face separate exclusions. It becomes possible when the claim is tied to a specific technical improvement, like sensor accuracy or processing efficiency, rather than the diagnostic conclusion itself.
What's the Alice/Mayo test, and why does it matter for health-tech in the US?
It’s a two-step framework used to determine whether a software or diagnostic-related claim is merely an abstract idea (not patentable) or adds enough of a genuinely inventive technical application to qualify for a patent.
How is a wearable device's sensor technology different from its software, IP-wise?
The sensor hardware and its underlying engineering are typically protected through utility patents. The software analyzing the sensor data is protected through a mix of patents (if tied to a technical effect) and copyright (for the code itself).
Building a health-monitoring device, app, or platform and not sure how to protect it? PATHtoIP can help you map it out, reach out at info@pathtoip.com.
