Q&As

Which laws and regulations govern health care apps (mHealth)?

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Published on LexisPSL on 19/03/2019

The following Local Government Q&A provides comprehensive and up to date legal information covering:

  • Which laws and regulations govern health care apps (mHealth)?
  • Regulation as a medical device
  • Data protection
  • Healthcare regulation
  • Intellectual property

Regulation as a medical device

An app may, depending on the specific characteristics and intended use, fall within the definition of a medical device. Practice Note: An introduction to the regulation of medical devices provides a useful starting point. The regulatory regime imposes obligations on manufacturers of medical devices and in vitro diagnostic medical devices to ensure that their devices are safe and fit for their intended purpose. In order to be placed on the market in the EU, all medical devices must meet the 'essential requirements' set out in the relevant medical device directive.

To determine whether the app would fall subject to the medical device regulatory framework, the section ‘An introduction to the regulation of medical devices—What is a medical device?’ from the aforementioned Practice Note provides the definition of a medical device as:

'any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings to:

  1. diagnose, prevent, monitor, treat or alleviate disease

  2. diagnose, monitor, treat, alleviate or compensate for an injury or handicap

  3. investigate, replace or modify the anatomy or a physiological process

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