Legal advice on wearables in the healthcare industry

Wearables & tracking devices

Wearables that strike the right balance between innovation and legality

We provide advice on data protection and data law to ensure that connected health devices can be developed, marketed and used securely.

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What are wearables in healthcare?

Wearables, or tracking devices, are devices that continuously monitor vital signs to promote preventive health measures and are generally considered to be part of the Internet of Things. Common applications include ECGs, glucose monitors (CGM) or blood pressure monitors. Vital signs are usually measured using wristbands or watches, or biosensors in the form of patches.

What are the challenges facing developers and providers of health wearables?

Privacy:
The privacy requirements for processing health data are particularly high because of the sensitive nature of the data. Privacy by design and by default is particularly important.
Information security:
Providers will need to implement comprehensive cybersecurity measures to protect sensitive health data from cyber-attacks and unauthorised access.
Consent management:
Users must be able to give their consent to data processing in a targeted and transparent way. This is particularly difficult for wearables without an application interface.
Data re-use:
The processing of health data that has already been collected for research purposes or product improvement is subject to particularly strict regulations.
Involvement of external service providers:
Service providers involved in data collection, storage or processing must meet strict requirements and be contractually involved in data processing (e.g. order processing agreements).
Interoperability:
Developers and vendors must ensure that data can be transferred across devices and systems without altering the data.

How we can help you with health wearables

Life cycle support: We provide legal and technical support from the development of your product to its sale.
Comprehensive data protection and information security advice: We help you comply with GDPR and other data protection regulations, as well as IT security to ensure the protection of sensitive health data.
Data protection audits and DPFA: We conduct data protection audits and conformity assessments, including data protection impact assessments, and prepare legally compliant data protection declarations.
Contract drafting and review: We draft and review contracts specifically tailored to the development of health wearables (e.g. order processing contracts or joint controller agreements).
Data access and trade secrets: Advice on data access and the protection of data and trade secrets, taking into account the relevant regulations (including the Data Protection Act, the EHDS, the Law on Trade and Commerce and SGB V).
AI advice: Advice on compliance with legal requirements for artificial intelligence - in particular the AI regulation.
Extrajudicial and judicial representation: We represent you in the out-of-court enforcement and defence of claims as well as in administrative and judicial proceedings.
Compliance training: We provide tailored training for your team to ensure that all employees are aware of the legal requirements in the eHealth sector.

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Intro

Our motto: secure, radical, digital.

SRD is the boutique law firm for digital projects, supporting you from kick-off to go-live. We combine technical innovation with compliance. We create radically clear legal scope for this.