Consulting on eHealth solutions

eHealth

Secure and legally compliant in the digital health sector

Innovative health technologies require a robust legal foundation. Our law firm can provide you with the comprehensive advice you need to ensure that your eHealth solutions comply with legal requirements.

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What is eHealth?

eHealth refers to the use of modern information and communication technologies (ICT) in the health sector to improve medical care, facilitate access to health services and make administrative processes more efficient. It includes digital health platforms, electronic patient records, telemedicine, mobile health applications (mHealth) and the analysis of large amounts of health data. eHealth opens up new opportunities but also places high demands on privacy, data security and regulatory compliance.

What are the eHealth use cases?

eHealth umfasst eine breite Palette von Anwendungen, die das Gesundheitswesen digital transformieren und die Versorgung sowohl für Patienten als auch für Gesundheitsdienstleister verbessern. Von der Verwaltung medizinischer Daten bis zum Einsatz künstlicher Intelligenz bietet eHealth zahlreiche Möglichkeiten, die Effizienz und Qualität der Gesundheitsversorgung zu steigern.

Health Apps: Specialised applications for health monitoring, medication reminders, fitness tracking and more that actively involve patients in their healthcare.
Wearables and Tracking Devices (IoT): Devices for the continuous monitoring of vital data that promote preventive health measures and are generally categorised as part of the Internet of Things.
Artificial Intelligence: Use and development of AI-supported healthcare solutions.
Cloud Solutions: Storage and exchange of healthcare data in secure cloud environments that facilitate access and improve collaboration between different healthcare organisations.
Telemedicine and Healthcare Platforms: Virtual doctor visits or appointment booking platforms enable easier access to healthcare regardless of location.
Telematics Infrastructure (TI): Secure digital network in the healthcare sector for faster exchange of healthcare data (e.g. through e-prescriptions, e-patient files or e-health cards)

What are the challenges for companies & organisations in the eHealth sector?

Companies and organisations operating in the eHealth sector face a number of legal challenges that must be carefully considered in order to offer successful and legally compliant digital health solutions.

A key concern is data protection, in particular compliance with the General Data Protection Regulation (GDPR), as healthcare data is considered particularly sensitive. Ensuring data security and protection against cyberattacks are also essential in order to gain the trust of users and fulfil legal requirements. In addition, legally compliant service provider management and compliance with the requirements of the fifth German Social Code (SGB V) are fundamental.

Other challenges may include the connection to the telematics infrastructure (TI) and inclusion in the DiGA/DiPA directory at the Federal Institute for Drugs and Medical Devices (BfArM).

How we can help you with eHealth

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.
Privacy audits and DPIAs: We conduct privacy audits and compliance assessments, including privacy impact assessments.
Contract drafting and review: We draft and review contracts specifically tailored to the requirements of eHealth services and technologies (e.g. service provider contracts, DPAs or joint controller agreements).
Support with apps & wearables: We support you in the development, distribution and use of health apps and IoT products.
AI compliance: We work with you to develop AI governance structures for your AI solutions (use and/or development) and prepare you for the requirements of the AI Regulation.
Telemedicine and platform advice: We help you to implement telemedicine services in a legally compliant manner and to comply with platform regulations.
Audit of cloud solutions: We examine the legal possibilities of using the cloud, determine the necessary measures and support the implementation.
TI consulting: We advise you on the specific requirements and needs of the telematics infrastructure and help you implement it.
Out-of-court and court representation: We represent you in the out-of-court enforcement and defence of claims, as well as in administrative and judicial proceedings.
Advice on public procurement procedures: We advise contracting authorities as well as IT service providers or technology companies in procurement procedures in the healthcare sector (e.g. in the area of telematics infrastructure).
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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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.