The home fitness market is booming with an estimated turnover of over 10 billion prioritizing their health and fitness. Innovative technologies and related apps like smart treadmills and spinning bikes to monitor heart rate and smart dumbbells to monitor arm movements have proven to be very popular fitness equipment, but they bring new legal challenges with them. We discuss some of the regulatory issues surrounding home fitness products and the technologies they use.

Security requirements

Home fitness products should not be placed on the market if they are not considered “safe” under EU and Irish product safety regulations. According to the General Product Safety Directive (GPSD), in order to be safe, under normal or reasonably foreseeable conditions of use, a product must present no or minimal risks that are compatible with the use of the product that is deemed acceptable and compatible with a high level of protection for the safety and health of people. Manufacturers should be aware of their potential obligations and liabilities under the Product Safety Act.

Depending on the product type, this can also refer to product-specific guidelines such as B. Extend Directive 2014/53 / EU (Radio Equipment Directive), Directive 2014/35 / EU (Low Voltage Directive) and Directive 2014/30 / EU (Directive on Electromagnetic Compatibility (EMC).

In this context, it should be noted that the European Commission has presented its proposal for a new General Product Safety Regulation (GPSR), which would fundamentally change and replace the current GPSD. Although software is not specifically included in the definition of a “product” in the new text, the proposed regulation would expand the aspects of assessing the security of a product to include protection against cybersecurity risks. In addition, the definition of “product” in the proposed regulation explicitly includes a reference to objects that are connected to other objects.

Appropriate warnings

According to the GPSD, when determining whether a product is safe, warnings and instructions for its use are taken into account. The fact that home fitness products are naturally used at home and not at a designated workout or gym creates the risk of unintentional users, such as children, accessing them and injuring themselves.

Therefore, it is important that manufacturers put warning labels on home fitness products in order to comply with their legal obligations, particularly about who should use the products, where and how they should be used. If a manufacturer knows or has reason to believe that their home fitness products are being used for purposes other than those for which they are intended, they still have obligations and obligations towards users, including relevant disclaimers and warnings.

Is the product a medical device within the meaning of the Medical Device Regulation (MDR)?

For every consideration of the regulatory risks of home fitness products, it is crucial whether these products could be medical devices within the meaning of the MDR. Products, including software, designed for a variety of “specific medical purposes” including diagnosing, preventing, monitoring, predicting, treating, or alleviating a medical condition fall under the definition of a medical device under the MDR. Home fitness products that are classified as medical devices according to the regulation are subject to strict requirements. These obligations are determined by a risk assessment of the device, including clinical trials, conformity assessments by notified bodies, CE marking and post-market surveillance. Placing a product on the EU market that does not meet these requirements can lead to regulatory enforcement actions, including fines or a forced recall of the product from the market.

The way in which a product is presented to potential users (ie certain health-related claims) can also qualify the product as a medical device within the meaning of the MDR. Therefore, manufacturers and developers should carefully review marketing and promotional materials to ensure that any claims made about the product do not create the impression that it is intended for any of the specific medical purposes provided for in the definition of a medical device. Such claims could inadvertently bring the product within the scope of the MDR.

Privacy considerations

Home fitness technologies can collect significant amounts of data about their users. Therefore, GDPR compliance obligations are critical for manufacturers of these products. Topics to consider include:

  • Transparency towards users and provision of information about the data that is collected and generated when using the technology and how this data is used. This information should be easily accessible and easy to understand for users. Providing adequate information to users regarding their privacy can be challenging, especially for devices with small screens. The use of easily accessible online privacy notices and appropriate linking and layering of the full privacy policy should be considered by the manufacturers of such devices when providing this information.

  • Understand whether they are collecting “health data” within the meaning of the GDPR. Since health data (or genetic or biometric data) are particularly sensitive, they are referred to in the GDPR as a “special category of personal data” that must be additionally protected. This often means that a manufacturer must obtain the explicit consent of the user prior to use. The answer to this question depends on the picture the data paints of the user’s health. Simple step count data probably doesn’t qualify as health data, but step count, diet, heart rate, and blood pressure combined could be. Manufacturers must take additional precautions when processing this category of data.

  • Ensure adequate security measures to protect the data and ensure that the technology is developed in accordance with the GDPR rules on data protection by design and standard. These rules mean that data protection cannot be an additional consideration at the end of the product development process, but must be taken into account from the start.

Use of artificial intelligence

Many home fitness products are now also integrating AI into their design. The complex properties of these technologies are not explicitly dealt with in the existing legislation, which poses challenges for product safety. This has prompted the European Commission to publish legislative proposals that providers, users, importers and distributors of AI should take note of. For example, the GPSR proposal of the European Commission will add the evolving, learning and predictive functions of the product to the aspects of assessing whether a product is safe under the GPSD.

In addition, the European Commission has proposed a new AI-specific regulation. This regulation introduces strict requirements for AI systems that are classified as “high risk” before they can be placed on the EU market. This includes having adequate risk assessment and mitigation systems, using high quality data sets to minimize risk and discriminatory outcomes, and logging activities to ensure traceability of outcomes. AI systems classified as low-risk, such as chatbots, will have less burdensome transparency obligations, provided that users need to be able to make an informed decision about whether to interact with such systems. Finally, AI systems that are classified as minimal risk that pose little or no risk to the rights or safety of citizens (most AI systems according to the European Commission) will not be subject to new obligations.

graduation

Home fitness products present their manufacturers with many regulatory challenges and risks, especially when it comes to innovative new technologies. Manufacturers need to ensure that the home fitness products they place on the EU market are safe and have appropriate warnings attached to them. The intended use of these products should be carefully considered as this could lead to burdensome MDR obligations and penalties for non-compliance. Home fitness product manufacturers who collect data from their users should be aware of their GDPR obligations, while those who use AI should closely monitor legal developments in this area.