The Rush to Smart Phone and Tablet Apps

The rush to generate smart phone and tablet apps may have had a warning shot fired across companies’ bows that people are choosing to ignore, or may simply be unaware of.

Using Medical apps as an example, there are an estimated 40,000+ medical apps in release now. Only ONE that I am aware has received U.S. Government Food & Drug Administration (FDA) Approval. The FDA has been working on smart phone apps standards for medical devices since July, 2011. It has reason to be concerned. Estimates are that at least 500 million Smartphone users worldwide will be using a health care application by 2015. The FDA is focused on oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.

FDA`s initial focus is on a relatively small subset of medical devices. BUT, if people are using medical apps to manage or monitor aspects of their lifestyle, for example, a question arises: When does something simple and innocuous impact or threaten your life? When it`s wrong or you misuse it. And there are significant security issues, as well as compliance with the US HIPAA and other international requirements for personal and health information transmission and security.

Bottom line: there may be several-to-many levels of potential liability in smart phone apps for both users and developers. E.g., apps don’t operate properly, have bad data, or are miss-constructed and leak personally identifiable or personal health information to a social media site in violation of a number of federal laws. Or for commercial apps, consider leaking information that violates the US Sarbanes Oxley Act or one the many SEC regulations, or the Trade Secret Law and Economic Espionage Act of 1996. Push button, post or distribute data by accident. That can happen, and has happened in the past.

Many standards from a variety of sources affect mobile apps in one way or another. It is in the best interests of the developer, the individual and corporate user, and industries as a whole, to REALLY get a grip on these varying requirements, and ensure compliance. REALLY understanding underlying statutory and regulatory requirements decrease the likelihood of something bad-to-tragic happening.

Established firms probably get it. New Co Start ups need to educate themselves to avoid pitfalls that could kill them. Savvy Investors will ask tough questions and wrong answers will stop you in your tracks.

Bottom line recommendation?

BUYERS: check out what you’re getting into, test a broad range of permutations of use, verify the security or integrity of the app, and still proceed carefully and with oversight.

PRODUCT/APP Builders: be sure you are in-bounds with statutory, regulatory, and policy items that exist and change from time to time and may affect your efforts. If you are selling to the Feds, state and local government, you can be sure there are such items.

Remember: oversight is not luxury you can afford in this new electronic world of ours.

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