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Medical device software is growing fast and so are the myths around it. We often hear assumptions about FDA compliance, usability, and security that just aren’t true. Assumptions are not facts, so let’s separate the two and talk about what actually matters in practice.
At Promenade Software, we work with innovators and medical device manufacturers to build apps that meet real-world needs. Along the way, we’ve noticed that myths can sometimes overshadow the facts. Let’s clear the air.
Many people assume health and wellness apps are FDA regulated simply because they claim to support healthy living, but unlike true medical device apps, most aren’t, creating a false sense of security.
Fact: Not every app labeled as “health” or “wellness” qualifies as a regulated medical device app. The FDA only regulates apps that meet its definition of a medical device and could pose a risk to patient safety. For example, fitness trackers and step counters usually aren’t under FDA review, while apps that monitor heart conditions or insulin dosing may be.
Let’s be honest, most of us have struggled with a clunky app at some point. Many people feel if an app is tied to something as serious as healthcare, it must be complicated or intimidating.
Fact: Modern medical device software development emphasizes usability and accessibility. In fact, the FDA requires usability studies. Developers increasingly design apps that are intuitive for both patients and clinicians. Clear instructions, thoughtful interfaces, and attention to user experience are now industry standards. Far from being overwhelming, many apps are designed to reduce complexity and improve engagement.
It’s easy to assume that if an app handles health data, security is a given.
Fact: Security and privacy aren’t automatic and they’re not the same thing. HIPAA (Health Insurance Portability and Accountability Act) applies only when PHI (Protected Health Information) is handled by a covered entity or its business associate, so many consumer health apps may not be covered at all. And even when HIPAA does apply, strong security must go beyond privacy to protect the full CIA triad:
Well-designed apps use encryption (in transit/at rest), access controls, audit logging, testing, and ongoing monitoring. Users should review who is responsible for the data and what security commitments the app actually makes before sharing sensitive information.
From the outside, medical device related apps can look similar: log in, enter info, see charts. To the average user, it can appear as if they’re all doing the same thing and offer the same level of accuracy or safety.
Fact: True medical device apps are validated, tested, and often integrated with medical-grade hardware, designed to support clinical decisions. Health and wellness apps, by contrast, are mostly for personal tracking, with limited accuracy and minimal oversight. Confusing the two can give users a false sense of security, especially if they rely on the app for health decisions. Although most health and wellness apps work in similar ways, medical device apps are each designed with a distinct and highly specific purpose:
Medical device software is becoming central to care. The important part is dealing in realities, not assumptions. When we separate myth from fact, patients, clinicians, and product teams can choose and use these tools safely and effectively.
At Promenade Software, we design and build FDA-compliant, user-friendly, and secure applications for medical devices. We combine regulatory expertise with practical UX and modern cybersecurity to help clients deliver software that truly improves care.
Have questions about compliance, usability, or security? We’re glad to share perspectives from recent projects.
