A demo of the Mixed Reality Viewer, a technology that produces hyper-realistic 3D patient data

Public AffairsShaping 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.

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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.

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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.

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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.

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.

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.”

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.

A demo of Cirq®, a robotic surgical system
Stefan Vilsmeier in conversation with federal president Frank-Walter Steinmeier
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A demo of Cirq®, a robotic surgical system
Stefan Vilsmeier in conversation with federal president Frank-Walter Steinmeier
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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 of Conduct

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)
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Memberships in 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

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

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

Grüner Wirtschaftsdialog e.V.

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

Wirtschaftsforum der SPD e.V.

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

Wirtschaftsbeirat der Union e.V.

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

Lateinamerika Verein e.V.

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

Our Team

Interested in learning more about our vision and involvement in policy making for health data? Contact our Government Affairs team.

Director Government Affairs Martin Wisböck

Martin Wisböck

Director Government Affairs

Phone: +49 89 99 1568 0
Mail:

LinkedIn

Additional Resources

Discussion PapersStefan Vilsmeier as Contributing Author
Key Considerations for the European Health Data Space (English)
Download
Impulse for a German Law on the Use of Health Data (German)
Download
Impulse on the Proposal of a European Health Data Space
DEEN
10 Main Critique Points on the Proposal of a European Health Data Space (German)
Download
Impulse on the Proposal of a European Data Act (German)
Download