Public Affairs

Shaping Policy Today
to Support
Innovation Tomorrow

Laws, regulations and policies shape healthcare and impact advancements in research and the industry. Our goal is to share our insights with policymakers while remaining fully accountable and transparent.

When it comes industry innovation and health data, our vision is grounded in three words: Access. Utilize. Protect.

83%^* of Germans are willing to donate their health data

Patients need full control over their health data – who can use which data for which purposes needs to be up to them. 83%^* of Germans are willing to donate their health data for research purposes.

Access and safety go hand in hand

Germany must strike the right balance between leveraging the opportunities and mitigating the risks that arise from digitization and data use. This does not mean abandoning European values, but rather synchronizing the implementation of regulatory measures with the promotion of a data economy. Only a stronger focus on the economic framework for access to data can secure future technical, economic and social innovation in Germany and Europe.

Standardizing electronic access

In addition to regulatory requirements for data sharing, there is a lack of technical options for patients to practice informational self-determination or decide what happens to their personal data.

Granting patients access to their own electronic patient file is a step in the right direction, but all of the health data collected over time is by no means all stored in that one file. To prevent the development of tedious and difficult-to-use hospital information systems, medical facilities should guarantee that patients have electronic access to all of their data recorded onsite via a technically standardized interface, which can also serve as a bridge to the electronic patient file.

^*https://www.bitkom.org/Presse/Presseinformation/Grosse-Offenheit-fuer-Spende-von-Patientendaten

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Using digital technologies can save up to €42^* billion

To do justice to the enormous potential of health data, legislators must provide us with clear rules for its use. The healthcare system could save up to €42^* billion through the use of digital technologies.

Improving treatment with health data

The use of healthcare data is revolutionizing value creation and the way the entire healthcare system works. Patients benefit from tailored therapeutic approaches and improved diagnoses. Hospitals optimize their work processes. Doctors can plan their interventions more efficiently and precisely, thus enabling them to spend more time on patients. Companies are also able to establish new, innovative areas for business and further improve their existing products.

This enormous potential must be supported by the right laws and regulations. However, skepticism about the use of data is still widespread and inhibits the development of an economically significant data economy. If we want to establish a competitive data market in Germany and Europe, we need one thing above all else in addition to innovative ideas: political courage.

Digital cancer registry in partnership with industry

The fight against cancer is a major challenge facing society both locally and globally. If Germany succeeds in linking excellent standard care with innovative technologies by means of data, it will be able to consolidate another globally significant pillar of the German economy.

A close dialogue between data protectionists, patient representatives, investors, service providers, IT companies, the pharmaceutical industry, medical device manufacturers, AI experts and politicians should lead to a consensus that sets global standards. The result must be an interoperable and validated data-oriented process that promotes innovation through standardized interfaces and public example data sets.

^*https://www.mckinsey.de/news/presse/2022-05-24-42-mrd-euro-chance

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Only 29%^* of internet users in Germany feel that their data is secure

Guaranteeing the highest level of security in handling health data must always be the top priority. Only 29%^* of internet users in Germany feel that their data is secure.

Accessing and utilizing data – responsibly

For a patient, sharing personal health data requires more than trust, it needs guarantees: Binding legal guidelines are needed to ensure anonymization and full transparency about who can access which data and for what reason. Brainlab actively supports the consolidation of binding foundations on ethical, transparent and controllable health data traffic.

Uniform data protection guidelines

In European as well as international competition a completely fragmented and inconsistent interpretation and application of the GDPR is a major obstacle for all companies in the data economy. This practice does not increase data security for individual or societal benefit but complicates the work of companies and citizens alike. The state data protection authorities should therefore develop uniform guidelines, which should then be interpreted by the data protection supervisory authority of the respective state in a binding manner throughout Germany.

Separating business data and health data

It is problematic when large internet corporations link particularly sensitive patient data generated by digital health applications with personal information from other business areas to form comprehensive user profiles and exploit them commercially. Citizens must therefore be protected in this particularly sensitive area. There needs to be a clear separation of business areas that store and process data generated by digital health applications and those that store and process data from services in other business areas, for example, search engine queries, position data and voice data. This is the only way to effectively prevent profiling.

^*https://de.statista.com/statistik/daten/studie/872116/umfrage/
einschaetzung-der-sicherheit-von-persoenlichen-daten-im-internet-in-deutschland/

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Legal Frameworks

EU Data Governance Act

The European Data Governance Act acts as a legal foundation for a European data exchange framework, dismantling technical and regulatory barriers across borders and actively promoting “data altruism,” the donation of data for research purposes.

More information

EU Data Act

The European Data Act complements the Data Governance Act by regulating the parties and conditions of data exchange. The latter focuses on cross-border data interoperability, a user’s right to forward produced data to a third party and protecting Small and Medium Enterprises (SME) from unilaterally beneficial data sharing contracts.

More information

European Health Data Act

By establishing a common data space for Health data, the European Commission aims to promote better exchange and access to different types of data. In this way, an infrastructure called “Data Space” is to be created in a transparent manner and on the basis of fundamental European values, which will drive the use of primary and secondary data. In addition to building an infrastructure, the Data Space will also define standards for data quality and thus interoperability of different national health platforms, as well as develop a common governance structure. In May 2022, a concrete regulatory proposal was published.

More information

Medical Device Regulation

Replacing the Medical Device Directive, the Medical Device Regulation sets new quality and risk management standards for medical device manufacturers. Technical documentation regarding essential safety and performance requirements is regulated more strictly in that an employed regulatory compliance expert is mandatory. Currently in a transition timeline, manufacturers need to request (re-)certification of their products by “Notified Bodies.”

More information

Responsibility & Transparency

The development of laws and regulations is a two-way street. Companies need to be well informed about existing and planned legal conditions so they can adapt their actions accordingly. It is also essential that industry experts make their knowledge available to decision makers in a transparent and professional manner.

This knowledge can inform public authorities about the consequences of their decisions, which alternatives might be possible, or, proactively, where legal certainty needs to be improved. Ill-considered legal frameworks could jeopardize medical technology locations in Germany, and with them tax revenues and jobs. This support is not at odds with transparency: We are always ready to share the viewpoints and ideas that will serve our mission – making an impact on patients’ lives.

Transparency Registers

Transparency registers enable companies to demonstrate their own values and clearly separate themselves from unethical or illegal activities. Brainlab therefore welcomes any form of mandatory transparency in the form of registers at various levels. Transparency registers allow the press and the public to get their own picture of private actors, as well as to judge their expenditures and contacts with the public sector. Transparency promotes information, and information promotes democracy.

State level

Some federal states in Germany maintain lobby registers and require registrations under different modalities. Nationwide, Brainlab is listed in the Bavarian Lobby Register. Since early 2022, companies wishing to represent interests vis-à-vis the Bavarian Parliament or the Bavarian State Government must register here.

See state level registry (PDF)

Federal level

Since the beginning of 2022, all interest representatives must register in the lobby register of the German Bundestag (federal parliament) with the intention to contact members of the German Bundestag or the Federal Government for the purpose of influencing decision-making processes.

See federal level registry

EU level

The European Transparency Register is an EU-wide database of companies and organizations that seek to influence decision-making processes at the EU level. Brainlab is voluntarily registered in this non-mandatory database. However, a quasi-mandatory register is being sought at an EU level, a move we very much welcome.

See EU level registry

Code ofConduct

Beyond local legal and regulatory guidelines, we commit ourselves to the highest ethical, environmental and economic standards in every aspect of our operations. Each of our employees must act in accordance with rules set out in our Code of Conduct, which defines how we behave towards each other, other companies, the public sector, patients and also the environment. We take strict care to ensure that all employees are aware of the contents of our Code of Conduct, and we do not tolerate any violations.

Code of Conduct (English, PDF)

Membership Associations

Participation and representation on state, national and international levels need teamwork. Since legislative decisions often impact whole industries, rather than each working on their own, companies connect within trade associations in order to aggregate their voices. In strict compliance with competition laws, associations help to inform their members about developments in business and politics that are relevant to them and jointly take and communicate viewpoints both reactively and proactively.

BVMed (German Medical Technology Association)

Representing over 240 manufacturers, distributors, and suppliers in the MedTech and medical provider industry, among them some of the world’s largest medical device manufacturers, BVMed connects and supports its members in grasping and shaping legal frameworks that regard this highly regulated industry.

BVMed

Ostasiatischer Verein (German Asia-Pacific Business Association)

The OAV offers the exchange of expertise and experience in business activities with Asia. Events, initiatives, and publications help the association’s members to stay informed about the volatile developments in this dynamically growing market and support them utilizing its potential.

Ostasiatischer Verein

Grüner Wirtschaftsdialog e.V. (Green Business Dialogue)

The Grüner Wirtschaftsdialog (Green Economic Dialogue) aims to provide its members with a platform that promotes the exchange of positions and ideas between politics and economy from the perspective of sustainable transformation towards an eco-social market economy.

Grüner Wirtschaftsdialog e.V.

Wirtschaftsforum der SPD e.V. (Economic Forum of the SPD)

Founded in 2015, the social democratic “Wirtschaftsforum” sees itself as a platform for companies of any size promoting an exchange between political and economic leaders and consolidating the social market economy in Germany and Europe.

Wirtschaftsforum der SPD e.V.

Wirtschaftsbeirat der Union e.V. (The Economic Council)

The Bavarian Economic Council is a politically independent association and represents nearly 1,900 companies, from SME to multinational. It provides a network for its members and leaders in Bavaria, Germany and the EU. Its vision is a modern economic and social system and economic policies close to the social market economy of Ludwig Erhard.

Wirtschaftsbeirat der Union e.V.