As you design, market, and distribute a mobile health (mHealth) app that your customers will use to collect, share, use, or maintain individuals’ health information, it is likely you have questions about what U.S. federal laws apply. You may also wonder which federal agencies oversee various aspects of mHealth — including how this varies by how individuals, their health plan, or health care providers will use the app.  Depending on who is expected to use an app and how they will get and use the app (e.g.,

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As we’ve previously discussed, algorithms—step by step instructions (rules) to perform a task or solve a problem, especially by a computer—have been widely used in health care for decades.  One clear use of these algorithms is through evidence-based, clinical decision support interventions (DSIs). Today, we see a rapid growth in data-based, predictive DSIs, which use models created using machine learning (ML) algorithms or other statistical approaches that analyze large volumes of real-world data (called “training data”) to find patterns and make recommendations.

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The same basic technology that can predict what movie you might want to watch, what song you might want to listen to, or what item you might want to buy online, can also predict the onset of diseases, forecast costs of care, and recommend treatment options for your doctors, nurses, and pharmacists.
Algorithms are not new to health care. Indeed, an important and long-standing part of our Health Information Technology (Health IT) Certification Program has included Clinical Decision Support (CDS) certification criterion covering “rules-based” algorithms and software systems that use rules derived by experts,

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