HerbalEGram: Volume 11, Issue 11, November 2014

1. Who is the publisher/developer? Are they a recognized name or company? Do they have a functioning, professional website that explains who they are and their qualifications?
2. Who is the target audience for the app? Patients, physicians, or the general public?
3. How current is the information it contains? Has it been updated recently?
4. Read the reviews of the app, both positive and negative. Are there functionality issues? Does it work as described?

Companies increasingly are embracing smartphone app technology as a platform for healthcare and selfcare. In September 2014, Apple released a HealthKit app in its newest operating system, while Google responded by issuing Google Fit in October 2014. These apps allow users to enter a variety of health indicators, including resting heart rate, steps taken, calories consumed, and even specifics such as vitamin intake. In addition, users can create “medical IDs” for emergency personnel that list existing conditions, medications taken, and known food and drug allergies. Third-party apps also can interact with HealthKit and Google Fit, which combines all of the collected data in one place.

This increased reliance on technology to enhance and guide healthcare choices prompted the US Food and Drug Administration (FDA) to label smartphone apps as medical devices in 2013; they now fall within the purview of the agency’s regulation.

Telephone, music player, encyclopedia, game console, and medical device. What can your smartphone do for you?

Technology, Healthcare, and Regulation

As technology grows more sophisticated, the stakes for developer and user errors grow higher. The FDA issued a guidance document in September 2013 announcing its plans to take a more proactive regulatory stance towards applications that, in the agency’s words, “are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.”² An app that can control another medical device (e.g., an insulin pump) or that has the ability to display, transfer, or store medical device data is considered a medical device and is thus subject to FDA oversight.

Other health apps that do not fall into the categories listed above but “may be intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease” may also meet the definition of a medical device, but are considered to pose a lower risk to the public than apps that directly control existing devices such as insulin pumps. In the case of the former, the FDA will exercise enforcement discretion.³

Herbal medicine references are mentioned specifically in the language of the guidance: “Mobile apps that prompt a user to enter which herb and drug they would like to take concurrently and provide information about whether interactions have been seen in the literature and a summary of what type of interaction was reported.”³ However, the examples given in the guidance are not an exhaustive list, and most if not all herbal medicine apps fall under the FDA’s definition for a medical device. (However, apps strictly focused on identifying or cataloguing botanicals that make no mention of the medicinal uses of plants would not qualify as medical devices.)

In 2012, HerbalEGram Managing Editor Tyler Smith wrote on the topic of mobile apps designed by herbal and dietary supplement organizations; the article can be found here. Here are a few examples of the latest herbal medicine reference apps, which may or may not be considered medical devices per FDA regulation.

New Herbal Medicine Reference Apps*

Wild Medicine
(Free; Apple)⁴
Created by the New York Botanical Garden

An interactive companion to the New York Botanical Garden’s (NYBG) Wild Medicine exhibit, this app was created to enhance the experience of touring the Enid A. Haupt Conservatory. Even if the Bronx is too far to visit in person, the app contains photos as well as information about the featured plants and descriptions of their healing properties. Audio commentary from Vice President and Director of the Institute for Economic Botany at NYBG and American Botanical Council Board of Trustees member Michael J. Balick, PhD, as well as discussion on the latest botanical research from leading scientific and ethnobotanical experts, provides a unique dimension to the data. The app uses “augmented reality” technology — which adds information to an image the visitor takes with their device’s camera — to interact with the exhibit.

Natural Medicines Comprehensive Database
(Free; Apple/Android)⁵
Created by Therapeutic Research Center

This is the mobile version of the extensive database created by the Therapeutic Research Center, an advisory service for drug therapy and medication management and publishers of Pharmacist’s Letter, Prescriber’s Letter, and Pharmacy Technician’s Letter, the extensive Natural Medicines Comprehensive Database (which is in the process of incorporating information from the Natural Standard database), as well as corresponding Canadian publications. While the app itself is free, most of the information is accessible only by subscribers ($49/year for the consumer version and $299/year for the professional). However, the monograph on ginkgo (Ginkgo biloba) and list of United States Pharmacopeia (USP)-verified ginkgo products are available for free (but not the references).

First released in 1999, the database is updated daily with new research and includes evidence-based monographs on natural ingredients, effectiveness ratings, safety ratings, and interaction ratings. It also contains a list of brand name nutritional dietary supplement products (mostly non-botanical) that are verified by the USP. The monographs list information that many pharmacists would find useful, such as interactions with herbs, supplements, drugs, and foods; lab tests; diseases or conditions; as well as dosage guidance.

About Herbs
(Free; Apple/Web)⁶

Created by Memorial Sloan Kettering Cancer Center’s Integrative Medicine Service

Memorial Sloan Kettering Cancer Center, the world’s largest and oldest private cancer center, has a strong integrative medicine program to assist with symptom management and enhance patient care. The Center released its About Herbs app to serve as a quick reference guide to information on herbs, botanicals, dietary supplements, and complementary therapies that is available offline (i.e., a network or Internet connection is not required to view the material).

Each entry contains information at both professional and consumer levels, and multiple citations of scientific studies as well as study abstracts and links to the full text where available. Users also have the option to bookmark specific pages for easy access without searching. The entries for specific herbs include data on constituents, mechanisms of action, pharmacokinetics, warnings, reported adverse reactions, herb-drug interactions, literature summaries, and references.

Home Remedies
(Free; Android/Web)⁷
Created by ProThoughts

While the previous apps provided information on herbs, this app focuses instead on ailments. Users can scroll through a list of common, non-life-threatening conditions such as acne, blisters, and menstrual cramps for remedies that rely on botanicals and functional foods in the place of pharmaceuticals and conventional medicines. The guide is interactive, and users can submit their own home remedies and read through submissions from other users. Each remedy includes several suggestions for home cures, do’s and don’ts for treatment, and when a condition may warrant visiting a doctor. The app comes in two versions, Lite and Plus; the Plus version of the app contains more information and can connect to various social media accounts, allowing the users to share a remedy with their social circle.

Conclusion

Both the consumer and the professional with an interest in herbal medicine and natural healing can find a plethora of apps to assist with their healthcare and selfcare. These mobile references can be regulated by the FDA, but the growing numbers make complete oversight difficult; therefore, users are advised to research the origins of any health and wellness app, verifying that it comes from a trusted source and can be relied upon to contain accurate information.

* The listing and summary of the applications in this article are meant for educational purposes only and are not to be considered as recommendations by the American Botanical Council (ABC). ABC has not conducted a critical review of the information in any of these applications.

—Hannah Bauman

References

1. Mobile Medical Applications. US Food and Drug Administration website. Available here. Accessed October 27, 2014.
   
   
2. Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. US Department of Health and Human Services, Food and Drug Administration. September 25, 2013. Available here. Accessed October 27, 2014.
   
   
3. Examples of Mobile Apps For Which the FDA Will Exercise Enforcement Discretion. US Food and Drug Administration website. Available here. Accessed October 27, 2014.
   
   
4. App Tours for iPhone. The New York Botanical Garden website. Available here. Accessed October 27, 2014.
   
   
5. Natural Medicines Comprehensive Database App. Natural Medicines Comprehensive Database website. Available here. Accessed October 27, 2014.
   
   
6. Our mobile apps. Memorial Sloane Kettering Cancer Center website. Available here. Accessed October 27, 2014.
   
   
7. Apps. Home Remedies Natural Health and Healing website. Available here. Accessed October 30, 2014.