Open-source knowledge base for healthtech: medical devices, FDA & EU MDR regulations, telemedicine, wearables, and AI diagnostics. Trusted, verified guides.

HealthTech Wiki: The Open Encyclopedia of Health Technology

HealthTech Wiki is a free, open-source knowledge base dedicated to demystifying the intersection of healthcare and technology. We provide verified, neutral, and comprehensive guides on medical devices, digital health regulations (FDA, EU MDR), telemedicine platforms, wearable sensors, and AI-driven diagnostics. Our content is designed for clinicians, developers, regulators, investors, and patients seeking accurate, up-to-date information on the global health technology ecosystem.

 

Explore Core Topics

Medical Devices

Classifications (I/II/III), 510(k) vs. PMA, predicate devices, and IVD regulations.

Wearables & Sensors

Trackers, CGMs, ECG wearables, accuracy standards, and wellness vs. medical claims.

AI in Healthcare

AI/ML-enabled devices, diagnostic algorithms, training data, and adaptive algorithms.

Essential Reading for HealthTech Professionals

Frequently Asked Questions

Q: What is health technology (healthtech)?
Health technology refers to any application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of life. This includes medical devices, software as a medical device (SaMD), telemedicine platforms, wearable sensors, and AI-driven diagnostic tools.
Q: What's the difference between a wellness product and a medical device?
The distinction lies in the intended use and claims. A wellness product is intended for the general population to maintain or encourage a healthy lifestyle (e.g., stress reduction, sleep improvement) without claiming to diagnose or treat diseases. A medical device is intended to diagnose, cure, mitigate, treat, or prevent a disease or condition and is subject to stricter regulatory oversight (e.g., FDA 510(k) clearance).
Q: Do wellness wearables need FDA approval?
Generally, no. Most wellness wearables (e.g., fitness trackers counting steps or calories) are considered "general wellness products" and are exempt from pre-market FDA review, provided they do not make medical claims. However, if a wearable claims to detect a specific condition (e.g., atrial fibrillation or blood glucose levels), it is classified as a medical device and requires regulatory clearance.
Q: What is the EU MDR and who does it apply to?
The EU Medical Device Regulation (MDR) 2017/745 is the updated regulatory framework governing medical devices in the European Union. It applies to manufacturers, importers, and distributors of medical devices sold in the EU market, introducing stricter conformity assessments, clinical evidence requirements, and post-market surveillance obligations compared to the previous directive (MDD).
Q: What does SaMD mean in medical software?
SaMD stands for Software as a Medical Device. It refers to software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. Examples include AI algorithms for analyzing medical images, mobile apps for diabetes management, and clinical decision support systems. SaMD is regulated similarly to traditional medical devices.
Q: Is telemedicine covered by insurance?
Coverage varies by region and payer. In the United States, many private insurers and Medicare cover telemedicine services, though reimbursement rates and eligible services differ. In the EU, coverage depends on national health systems and specific bilateral agreements. Always verify with the specific payer and check for requirements like prior authorization or licensed provider status in the patient's jurisdiction.
Q: How do I ensure my health app is compliant with HIPAA or GDPR?
Compliance depends on the data handled. HIPAA applies to protected health information (PHI) in the US held by covered entities (providers, payers). GDPR applies to personal data of EU residents, with stricter consent and data minimization rules. Key steps include implementing encryption, access controls, data anonymization, and obtaining explicit user consent. Consult legal counsel for specific implementation.

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Every article is reviewed by clinical and regulatory experts to ensure accuracy and neutrality.

Primary Sources

All claims are backed by citations to official regulatory documents (FDA, EMA, EU Commission) and peer-reviewed literature.

Transparent Updates

Regulatory guides are reviewed every 6 months to reflect the latest policy changes. Last updated: October 2026.

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Our content is licensed under CC BY-SA 4.0. We welcome contributions and corrections from the community.

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