Health apps, fitness trackers, patient data analytics, virtual consultancy and digital billing: modern information and communication technologies are becoming increasingly important in the life science and healthcare sectors.
We regularly advise clients on the legal requirements for eHealth services as well as on product development and offer support with obtaining the relevant certifications. We advise developers of healthcare applications, digital service providers in the healthcare sector, billing centres and eHealth platforms as well as also various other business that process health-related data.
We are familiar with the special requirements for handling health data. We provide support in complying with data protection law and the increased technical requirements for appropriate data security. We design effective and manageable consent prompts for our clients' services and advise on the evaluation and analysis of patient data, for example for the purpose of medical studies. Compliance certifications exist that can be used to demonstrate the implementation of specific requirements. We advise on both the selection and the obtaining of different compliance seals.
We also assist with the regulation of eHealth services in specific areas. This includes mobile health applications, which –in connection with wearables or other devices – can collect and evaluate health-related information or even give medical advice . The broad possibilities call for individual and practice-oriented solutions.
Digital health applications have gained great importance in recent years. We advise in particular on the implementation of the requirements of the German DiGAV law and support our clients in meeting the criteria for listing in the official directory for fee reimbursement by the health insurance companies. When designing the app and during the application process, we assist both experienced healthcare businesses and start-ups. We provide comprehensive advice on the applicable privacy requirements, in particular on the compliance with the permitted purposes under the DiGAV and on the integration of providers in so-called third countries. Likewise, we continuously monitor the current legal developments in this area and planned new regulation, such as the electronic patient file.
We also regularly assess new digital business models in the field of eHealth, especially with regard to questions concerning the handling of health data or health-related information. Increasingly, businesses in the health industry are handling increasing amounts of patient data, digital health information and leverage and new medical technologies including AI and blockchain.
All of these business models require comprehensive planning. This also applies – in addition to privacy aspects – to the rights that are created and the behaviour towards competitors. This is why we also advise on the protection of intellectual property and the appropriate handling of IP within an organisation or together with business partners. We also have an eye for requirements under competition law within the health sector.