Data protection and IT security consulting for the healthcare industry

The ongoing digitalisation of the healthcare sector offers both traditional healthcare institutions and pharmaceutical companies immense opportunities to become more efficient and innovative with the help of new data-based technologies. This requires experience and expertise in handling healthcare data. This is the only way to fulfil the great responsibility, implement the corresponding data protection requirements and adequately prevent potential risks.

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Data protection in the pharmaceutical and healthcare industries: specific requirements and safeguards

Companies and institutions in the pharmaceutical and healthcare sectors regularly process special categories of personal data, i.e. data that is particularly worthy of protection. The protection of this data is regulated not only by the General Data Protection Regulation (GDPR) and the Federal Data Protection Act (BDSG), but also by numerous special laws, such as the Fifth Social Security Code (SGB V) and state-specific hospital laws. We support you in organising data processing processes in hospitals, doctors' surgeries and other healthcare facilities in a legally compliant manner, always keeping an eye on the applicable requirements in each individual case. In cooperation with caralegal Health, we can automate the most important compliance processes for you, such as the creation of a list of processing activities or the management of technical and organisational measures (TOM) on a software basis, taking into account the challenges faced by players in the healthcare sector.

Consulting for Pharma & Healthcare: Always up to date as part of continuous development

We have many years of consulting experience in the pharmaceutical and healthcare sector and highly specialised, sector-specific know-how. The dynamics and constant progress in the pharma & healthcare sector are reflected in our daily consulting practice. For example, we always take into account the regulations at national and European level, which are constantly adapting to technical progress. At the national level, we keep an eye on regulatory initiatives such as the planned Health Data Utilisation Act (GDNG), which aims to make health data accessible and usable for research, and the Hospital Future Act (KHZG). At EU level, the planned European Health Data Space (EHDS) will bring major changes - we will prepare you for this. For medical devices, it is also important to consider the new requirements arising from the planned regulation on artificial intelligence.

Digital transformation in the hospital sector: experience and expertise for effective patient management and implementation of electronic solutions

We also understand the specific needs of the hospital sector, which is facing particular challenges as a result of the digitisation of healthcare. We have a wealth of experience in dealing with digital patient management and the transition to the electronic patient record (ePA), the electronic medication plan (eMP) and the use of the emergency record. We also support you in the use of EVB-IT contracts (Supplementary Contract Terms for the Procurement of Information Technology). The introduction of the electronic health card (eGK) was and is relevant for hospitals, medical practices and care facilities, as is the increased use of telemedicine. As experts in this field, we are very familiar with the special features that need to be considered when connecting to the telematics infrastructure. We also advise pharmacies on the use of e-prescriptions.

As a competent partner, ISiCO helps you to meet the complex data protection requirements on the way to a digital healthcare system, to exploit the resulting opportunities and to identify and minimise the risks.

We offer practical approaches and tailored solutions that combine the tried and tested with innovation. We focus on digital and location-independent consulting that is tailored to your individual needs.

Data protection challenges in the pharma & health sector and our solutions

The increasing interconnectedness and digitalisation of the healthcare sector is leading to new business models and opportunities, but also to various challenges and high demands. These can be diverse and are illustrated below as examples from our consulting portfolio:

  • Legally compliant fulfilment of data protection information obligations
  • Create and implement comprehensive and global access policies
  • Ensuring and, where necessary, legally compliant release from confidentiality obligations
  • Strict requirements for the transfer of patient data
  • Legally compliant use of/research on patient data (implementation of anonymisation and pseudonymisation concepts)
  • Structured and practical data protection organisation
  • Selection of reliable contract processors (data outsourcing) as part of contract processing agreement management
  • Dealing with requests for information from data subjects and their families
  • Digital health applications (DiGA) and their data protection compliant interoperability for collaboration between different systems
  • Legally compliant data processing processes, implementation of GDPR requirements with regard to the particular sensitivity of health data
  • Innovations in healthcare and the resulting data protection challenges (e.g. AI, which can be used in both research and healthcare)
  • Incorporating the constantly adapting regulation at national and European level:
    o National: e.g. connection to telematics infrastructure, planned law on the use of health data (GDNG)
    o EU: Ongoing new legislation such as EHDS, framed by new DA/DGA legislation, new requirements for medical devices from the planned AI regulation and existing requirements from the Medical Device Regulation (MDR).
  • Digitisation of the healthcare system, taking into account the specific challenges of hospitals, medical practices, nursing homes and other healthcare facilities (digital patient management, electronic patient file (ePA), electronic medication plan (eMP), emergency data set, electronic health card (eGK), increased use of telemedicine).
    o Also: Advice on the use of EVB-IT contracts (supplementary contractual conditions for the procurement of information technology)
    o Hospital Future Act (KHZG)
    Innovations in research: improved access to/use of health data, easier exchange; e.g. in the form of the Health Data Use Act (GDNG)
    For pharmacies: Update on e-prescriptions

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Companies that already trust us

ISiCO: Benefit from our experience in pharmaceutical and healthcare consulting and our innovative solutions.

  • Many years of consulting experience in all areas of pharma and healthcare
  • Highly specialised and industry-specific expertise
  • Practical approach and tailored solutions that combine the tried and tested with innovation
  • Digital and location-independent consulting - at your site or in our offices in Berlin, Cologne and Munich on request

Your health data protection with ISiCO: The complexity of the legislation requires expert advice

Health privacy legislation is becoming increasingly complex and can be difficult for managers to understand. However, a comprehensive understanding of all relevant regulations is necessary to ensure compliance. Our experienced data protection and information security experts can help you create a legally compliant data protection and IT security policy and advise you on all levels of health data handling. Contact us now and benefit from our expertise in the healthcare sector!

Your strategy for the best protection

The basis of every good business relationship is trust. Strengthen the relationship with your customers with our expertise in data protection and information security. This will give your company a strong competitive advantage and allow you to concentrate fully on your business.

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Ihr ISiCO-Experte für das Thema:
Dr. Philipp Siedenburg
Director Datenschutz

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