Healthtech

Healthtech products face a layered regulatory stack. If your product qualifies as a medical device, it must comply with the Medical Device Rules, 2017 under the Drugs and Cosmetics Act. If it involves telemedicine, the Telemedicine Practice Guidelines, 2020 apply. Health data is among the most sensitive categories of personal data, and the DPDP Act requires compliance with all general data protection obligations, with heightened scrutiny expected for health data processing. If you operate in the EU, health data is a special category under the GDPR requiring explicit consent or a specific legal basis. Clinical trial data is governed by the New Drugs and Clinical Trial Rules, 2019. Consumer-facing health products must also comply with the Consumer Protection Act and advertising restrictions on health claims.

Healthtech IP typically involves multiple layers. The underlying software may be protectable by copyright and, in some cases, by patent if it produces a technical effect beyond being a computer program per se. Algorithms and proprietary methodologies are best protected as trade secrets through confidentiality agreements and access controls. Brand names and logos should be trademarked. If your product involves a novel device, design registration and utility patents should be considered. For AI-driven health products, the training data pipeline, model architecture, and fine-tuned weights each have separate IP and licensing implications. We advise on building an IP strategy that covers all layers of a healthtech product.

At a minimum: DPDP Act compliance for all personal data (consent, purpose limitation, data minimisation, breach notification), specific attention to health data handling practices and security safeguards, compliance with electronic health record standards if applicable, GDPR compliance if you serve EU users, clinical trial data compliance if your platform is involved in research, and IT security policies covering access control, encryption, and incident response. If your platform processes children’s health data, additional parental consent requirements apply. We build compliance frameworks that address both general data protection and health-sector-specific obligations.