The Importance of Digital Health Package Inserts

The Importance of Digital Health Package Inserts

Package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, and provides information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user -- the person who will take the drug or give the drug to another person, for example a minor. Inserts for over-the-counter medications are also written plainly.

In the US the document is called "prescribing information" or the "package insert" (PI) and layperson's document is called the patient package insert (PPI). In Europe the technical document is called the "summary of product characteristics" (SmPC) and the document for end-users is called the "patient information leaflet" (PIL) or "package leaflet".

Given the confusion about 1)which digital health product to prescribe for any given patient, 2) the fact that many products are actually consumer products designated to provide information and education, not diagnosis or treatment, and 3) most are not clinically validated or cost-effective, perhaps its time to require package inserts for the prescriber and the patients.

What is in a package insert is described and required by the FDA and includes:

  • Clinical pharmacology - tells how the medicine works in the body, how it is absorbed and eliminated, and what its effects are likely to be at various concentrations. May also contain results of various clinical trials (studies) and/or explanations of the medication's effect on various populations (e.g. children, women, etc.).

  • Indications and usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure). Physicians legally can and often do prescribe medicines for purposes not listed in this section (so-called "off-label uses").

  • Contraindications - lists situations in which the medication should not be used, for example in patients with other medical conditions such as kidney problems or allergies.

  • Warnings - covers possible serious side effects that may occur.

  • Precautions - explains how to use the medication safely including physical impairments and drug interactions; for example "Do not drink alcohol while taking this medication" or "Do not take this medication if you are currently taking MAOI inhibitors".

  • Adverse reactions - lists all side effects observed in all studies of the drug (as opposed to just the dangerous side effects which are separately listed in "Warnings" section).

  • Drug abuse and dependence - provides information regarding whether prolonged use of the medication can cause physical dependence (only included if applicable).

  • Overdosage - gives the results of an overdose and provides recommended action in such cases.

  • Dosage and administration - gives recommended dosage(s); may list more than one for different conditions or different patients (e.g., lower dosages for children).

  • How supplied - explains in detail the physical characteristics of the medication including color, shape, markings, etc., and storage information (e.g., "Store between 68 and 78°F ").

Of course, there would need to be some modifications, like:

  1. Safety and efficacy
  2. Cybersecurity risks
  3. Data security
  4. Data , privacy, ownership and transfer rights
  5. Side effects
  6. Designation as a consumer product or a diagnostic or therapeutic device
  7. Generic substitution possibilities
  8. Adverse app reactions
  9. App-app interactions
  10. Compatibility with other drugs or devices

One thing that will not be in the insert will be what all this costs to you or someone else who has to pay for it.

At this point you are probably thinking, "We have enough regulations and we love our APPs. So what if they don't make us any better." Go shove your insert. Next you'll be telling us it has to have all that cotton in the bottle too.

Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs on Twitter@ArlenMD and Co-editor of Digital Health Entrepreneurship.

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  • Gabe Reissman

    We need to know what we are taking to heal our body.

  • Ashley Whitehead

    Definitely agree with you

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Arlen Meyers, MD, MBA

Former Contributor

Arlen Meyers, MD, MBA is a professor emeritus of otolaryngology, dentistry, and engineering at the University of Colorado School of Medicine and the Colorado School of Public Health and President and CEO of the Society of Physician Entrepreneurs at He has created several medical device and digital health companies. His primary research centers around biomedical and health innovation and entrepreneurship and life science technology commercialization. He consults for and speaks to companies, governments, colleges and universities around the world who need his expertise and contacts in the areas of bio entrepreneurship, bioscience, healthcare, healthcare IT, medical tourism -- nationally and internationally, new product development, product design, and financing new ventures. He is a former Harvard-Macy fellow and In 2010, he completed a Fulbright at Kings Business, the commercialization office of technology transfer at Kings College in London. He recently published "Building the Case for Biotechnology." "Optical Detection of Cancer", and " The Life Science Innovation Roadmap". He is also an associate editor of the Journal of Commercial Biotechnology and Technology Transfer and Entrepreneurship and Editor-in-Chief of Medscape. In addition, He is a faculty member at the University of Colorado Denver Graduate School where he teaches Biomedical Entrepreneurship and is an iCorps participant, trainer and industry mentor. He is the Chief Medical Officer at and and Chairman of the Board at GlobalMindED at, a non-profit at risk student success network. He is honored to be named by Modern Healthcare as one of the 50 Most Influential Physician Executives of 2011 and nominated in 2012 and Best Doctors 2013.

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