Key Takeaways
Software as a Medical Device (SaMD) is often described as the “prescription-only” equivalent in digital health. The analogy feels intuitive: both SaMD and Rx drugs are tightly regulated because of their potential for harm. But the comparison isn’t perfect, and relying on it too heavily can lead to misconceptions about the value of non-SaMD solutions.
SaMD & non-SaMD Compared to Rx & OTC: Why Does it Matter?
How SaMD and non-SaMD are perceived shapes digital health strategy. Viewing them like Rx and OTC can wrongly suggest that non-SaMD solutions are less effective. In reality, they serve different purposes, both can deliver significant value depending on the use case.
SaMD & non-SaMD: It’s All About Use Cases
The key difference between pharmaceuticals and digital health is potency vs. purpose.
- Drugs: Rx vs OTC is based on potency. Stronger effects bring higher risks and stricter regulation (e.g., ibuprofen OTC at low dose, Rx at higher).
- Software: SaMD vs non-SaMD is based on intended use. Software that diagnoses, treats, prevents, or mitigates a condition qualifies as SaMD. Programs that support adherence, provide education, or track health metrics fall under non-SaMD.
This doesn’t make SaMD “stronger.” It simply serves a different role. Even within one app, some features may qualify as SaMD while others remain non-SaMD. Classification always comes back to use case, not potency.
SaMD & non-SaMD: Risk & Potential for Harm
Despite these differences, there is one area where the Rx/OTC and SaMD/non-SaMD comparisons align: risk.
- Pharma: Potency links directly to risk, side effects, overdosing, interactions.
- Software: Risk comes from consequences of misuse, a misdiagnosis, flawed recommendation, or patients relying on software instead of professional care.
As AI becomes more embedded in digital health, these risks increase. A SaMD error can have downstream effects just as significant as misuse of a prescription drug, though the risks manifest differently. This is why SaMD requires stricter regulation than non-SaMD.
Why This Matters for Pharma in 2025
For pharma and life sciences stakeholders, the takeaway is clear: non-SaMD solutions should not be dismissed as “less potent.” They deliver measurable value in areas like adherence, education, and patient activation, all critical to treatment success. SaMD and non-SaMD are complementary tools, and the right choice depends on the use case, not on perceived strength.
Smartpatient’s Role in SaMD & non-SaMD
At smartpatient, we help partners design and scale both SaMD and non-SaMD programs on the MyTherapy platform, trusted by over 12 million users worldwide across all major therapeutic areas.
Our ISO 13485-certified Quality Management System (QMS) and ISO 27001-certified Information Security Management System (ISMS) ensure we can safely operate regulated SaMD while delivering high-impact non-SaMD programs globally.
Turn Strategy into Action — Deliver Value to Patients and HCPs
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