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New safety requirements Thanks to the revision of the European eIDAS regulation, a true digital identity will be established at the European level, including the creation of a digital wallet to prove identity, store official documents and introduce new trust services. The growing de­ma­ter­i­al­isa­tion of exchanges, which gives everyone access to a wide range of goods and services, must go hand in hand with protecting users - citizens and businesses alike - against cybersecurity risks. It is only by providing a reliable, secure and harmonised framework for electronic identification and secure transactions that the EU will be able to meet the challenges of the "Digital Decade". With the revision of the eIDAS regulation, Europe is giving itself the means to achieve its ambitions. Why revise the eIDAS regulation? Regulation 910/2014 of 23 July 2014 (1), which essentially came into force on 1 July 2016, establishes a common framework for the mutual recognition of electronic means of identification and electronic signature systems to secure electronic transactions in the Union. After just a few years of application, the results are not up to the mark: a low number of notifications of electronic identification schemes, insufficient European interoperability and poor knowledge of the processes in place on the part of companies and individuals alike. Furthermore, while the needs of the private sector are growing, the eIDAS regulation still prioritises the needs of public service. It does not cover emerging uses in banking, finance, education, health, e-commerce, etc. The European Commission's "Digital Compass" plan proposes a new, more global trajectory. eIDAS 2: regulations tailored to a wide range of use cases The eIDAS 2 regulation should enable the development of new use cases. These include mobility (e.g., ticket verification, mobile driving licenses), employment (e.g., diploma certification), healthcare (e.g., electronic prescriptions) and online payments (e.g., strong authentication). In line with the real uses of individuals and businesses, the proposed regulation proposes an approach based on the following principles: large-scale experimentation and feedback to improve regulations and integrate them as effectively as possible within each member state. The test project, launched in April 2023, should continue until 2025, with an evaluation of project results and recommendations for implementing the regulations. What are the main benefits of eIDAS 2? From digital identity to the European digital identity wallet While eIDAS 1 has enabled the development of digital identity systems, notably with several levels of certification, elDAS 2 will go much further with the introduction of a Europe-wide framework for digital identity security. The European Digital Identity Wallet (EDIW) will enable people to:Prove their identity without resorting to national identity solutions alone. Store their data: the wallet can contain an electronic signature issued by a qualified service provider. Manage all their official documents in electronic format (e.g., driving licenses, medical prescriptions, university diplomas, residence permits). The data stored in the EDIW can be used for a wide range of services, such as car rental, airport check-in, university enrollment, apartment rental or opening a bank account. This digital identity wallet will be usable throughout the European Union, regardless of the country of issue. In addition, the major platforms will have to accept its use, notably to enable Internet users to prove their age. Digital identity service providers will be approved and monitored, and the EDIW will be supervised by a national trust authority, in France ANSSI.A digital wallet that creates value for EU businessesThis European framework should "create economic value by facilitating access to goods and services" and "significantly reduce the operational costs of electronic identification procedures" (2). Indeed, the system should facilitate the enrolment of new customers, while reducing the risks of cybercrime (identity theft, fraudulent payment, data theft). eIDAS 2 will thus support the digital transformation of small and medium-sized European businesses in complete security. Additionally, information from a single direction will reduce the administrative burden on public authorities and support the cross-border mobility of European citizens and businesses. Risks linked to the development of digital identity identified by the CNILWhile the digital identity wallet has various beneficial features, such as optional and free issuance, management left to the bearer, minimal use of data provided and easier access for citizens to their digital identity, the CNIL in France has warned against the risks posed by the proposal to create a "unique and permanent identifier" introduced by the European Commission. While this type of identifier facilitates the interoperability of national systems, it also gives rise to numerous risks of profiling, tracking of citizens and interconnection of files. The final version of the eIDAS 2 (3) regulation is silent on this point, even though many questions remain. What's new for trust services? Greater reliability of website authentication certificatesThe revision of eIDAS will enable authentication certificates to be issued on websites, reinforcing users' confidence in the quality of their content. Internet users will be able to rely more easily on authenticated sites, reducing the risk of fraud. The trust framework established by the revised version of the text includes some minimum safety obligations to be met along with rules for displaying data and other attested attributes. The obligation under French law to include certain legal notices on a website will probably have to be brought into line with these new obligations regarding the availability of qualified authentication certificates. New qualified trust servicesThe current list of trust services has been extended to include two new qualified trust services:the provision of electronic archiving services, defined as "a service ensuring the reception, storage, retrieval and deletion of electronic data and documents to guarantee their durability and legibility, as well as to preserve their integrity, confidentiality and proof of origin throughout the preservation period";the introduction of electronic registers, defined as "a sequence of electronic data records that should guarantee the integrity of these data and the accuracy of their chronological classification". Tougher requirements for advanced electronic signaturesThe revised text reinforces the security requirements and standards to be met by advanced signatures. These signatures must create an unambiguous link with the signatory, enable the signatory to be identified, and guarantee that the signed data has not been compromised. The means used to create these signatures must be under the sole control of the signing users (e.g., smartphone). Qualified remote signatures must meet the same requirements as those for advanced signatures but must be based on a certificate issued by a qualified trust service provider. While the eIDAS 2 regulation reinforces trust services, it should not be forgotten that these can be costly and complicated, and require the intervention of a qualified trusted third party. It is possible to argue that, if the European digital identity wallet proves effective, signatories could, in the future, be identified by this means alone in everyday transactions. The forthcoming entry of the revised regulation, and its first applications of digital identity in everyday life will, be a major step forward. This could lead to a merging of the notions of digital identity and digital authentication. To be continued... Key points: The new version of the eIDAS regulation, which will apply to entities will be published shortly in the OJEU. The amended regulation introduces the European digital identity wallet, which will enable users to prove their identity, store data and manage all their official documents. In terms of trust services, certificates for website authentication will be issued, new trust services will be introduced, and security requirements for advanced electronic signatures will be strengthened. Article published in Option Finance on 08/04/2024Reg­u­la­tion on electronic identification and trust services for electronic transactions within the internal market, or Electronic Identification and Trust Services Regulation, (eIDAS). Extract from the European Parliament's proposal for a regulation adopted  at first reading on February 29, 2024. The idea of creating a unique identifier appeared in the European Parliament's proposal of June 3, 2021, but is no longer expressly mentioned in the version finally voted on February 29, 2024. However, its use is not ruled out.

Berlin – As of May 1, 2024, Dr Kai Westerwelle joined CMS as a partner and strengthens the team headed by experienced CMS partners Dr Eckart Gottschalk and Dr Nicolas Wiegand, who will drive forward business development and marketing activities with US focus. Together, they will raise CMS’s profile as an international commercial law firm vis-à-vis US companies, US law firms and global corporations operating in the US and drive the expansion of the US business. Dr Kai Westerwelle is a Certified Specialist Lawyer for IT law and has more than 25 years of professional experience in leading European law firms in Germany. He has been based in Silicon Valley and San Francisco for almost ten years. There he has already successfully co-founded and scaled US offices of two major international law firms. He will now contribute his valuable experience in this area to CMS from his location in Silicon Valley. He specializes in IT and data protection law, tech transactions and international expansions. He mostly advises international clients, in particular US tech companies. Dr Eckart Gottschalk: "I am very pleased that with Dr Kai Westerwelle we have been able to attract a proven expert with many years of experience in the US market and excellent contacts in the USA." Dr Nicolas Wiegand added: "Together we will successfully expand our presence in the USA and the international advice we have been providing to US companies for many years."Press Con­tact presse@cms-hs. com

CMS Germany has opened a representative office in Silicon Valley on 13 March. This step underlines the CMS’ international commitment while also strengthening its presence in key global markets and business locations. The US hub will focus on business development and marketing activities. The aim is to raise CMS’s profile as an international commercial law firm vis-à-vis US companies, US law firms and global corporations operating in the US. CMS will also provide specific support to established US firms, start-ups and scale-ups. This will include assisting not only with their international business development and expansion into Europe, but also into South America, Africa, Asia and the Middle East. As an international commercial law firm, CMS benefits from the resources and expertise of a global network comprising more than 5,800 lawyers across more than 45 countries worldwide. This enables it to cover the need for first-class advice across the full range of commercial law in target markets that are new to US companies. CMS will continue to work with its “best friend” law firms in the US and will not be providing advice on US law. The representative office will be headed by two experienced CMS partners, Dr Eckart Gottschalk and Dr Nicolas Wiegand. Dr Eckart Gottschalk has years of experience gained through his work in Corporate/M&A at the CMS office in Hamburg. As the current Managing Partner of the CMS office in Hong Kong, Dr Nicolas Wiegand has wide-ranging expertise in establishing an international office and extensive knowledge of the US market. His focus is on international disputes and arbitration.

A unique life sciences Forum brought the legal challenges created by the rapid pace of technological advances into sharp focus with sector focused sessions and informative workshops. Experts from across the sector framed the incredible potential from digital and AI and called for the expertise of legal teams to take the ‘’regulatory handbrake’ off innovation that has transformative potential for healthcare systems and patients. CMS’s much-anticipated Global Life Sciences & Healthcare Forum 2023, co-hosted by Ellen Gielen, Roland Wiring and Gertie Lintjens, delivered a wealth of insight and ignited discussion about how regulatory frameworks can be tested and revised without compromising safety, security and compliance. Blurring Boundaries – Exploring the convergence of life sciences and law heard from leading figures from pharmaceutical companies, cutting edge AI enterprises, legal experts and biotech organisations with a strong accent on debate and collaboration. Marc Kaptein, Medical Director, Pfizer, revealed the unchartered territory he and his team had to tread during the pandemic as the company partnered with BioNTech to release a COVID vaccine and maximise its public uptake. In a fascinating talk, he outlined the twists and turns of the inside story of how Pfizer struck a rapid deal with BioNTech by ‘shaking hands’ and then balanced the societal benefits of maximising its vaccination with legal constraints designed to control public promotion.A willingness to break fresh ground legally, politically, scientifically and logistically was an integral part of the success story and he underlined to guests at the Forum, held in Amsterdam, that ‘without blurring boundaries, we would not have got where we are today’. Joep Rijnierse, Senior Medical Director at Amgen, highlighted its pioneering approach to  work closely with patient groups to generate therapy promise across a complete health condition. He said that the company’s medical departments worked with internal and external legal advisers to find ways to manage constraints in the mission to enhance all areas of healthcare delivery to improve systems and outcomes. Legal expertise is critical in shaping the landscape for AI developments and speakers from across the life sciences spectrum underscored the need for regulatory frameworks to evolve at pace. Life sciences is experiencing seismic change and Thibault Helleputte, the Founder and CEO of DNAlytics, revealed that the BioGPT initiative was able to identify medical hypotheses from deep in the data of 15 million papers in PubMed library to give scientists unprecedented R&D leads. The Forum was an opportunity to discuss how legal teams can use their skill and knowledge to ensure that regulatory frameworks did not impede progress and to explore fast and safe pathways for innovations to become working reality. Wouter Boon, Associate Professor in Innovation and Life Sciences at Utrecht University, emphasised the need to place legal aspects at the inception of the innovation process, observing that the sector was ‘highly regulated for all good reasons but it means that radical innovation has a tough job.’The Forum covered an impressive sweep of themes including AI, digital therapeutics, the challenges of multi-jur­is­dic­tion­al online pharmacies, the new EU medicines directive and co-creation with regulators.“We had a great range of speakers who focused on advances and roadblocks across the life sciences sector and provided us all with some innovative and provocative approaches,” said Nick Beckett, Global Co-Head of CMS Life Sciences & Healthcare Sector Group. “It was a fantastic opportunity to discuss, explore and collaborate and the insights and learnings it generated will help us face global challenges in life sciences.“We have to navigate global challenges such as sustainability, poverty, inequality, ageing populations; concerns about privacy with the use of data, concerns about ethics and the use of AI. To do that we need global perspectives and we believe that CMS as a firm, with 80 offices worldwide, is well positioned to navigate issues, foster collaborations and be a vital partner in moving life science innovation forward in the digital age.”

CMS Life Sciences & Healthcare Sector Group’s Forum 2023 provides expert insights, discussion and innovations to meet the challenge

14/03/2023We have been continuing to monitor the situation at Silicon Valley Bank on an international level since yesterday. Like the rest of the sector, we were relieved at announcement and welcomed news of the acquisition of SVB UK (the UK subsidiary of the SVB Group) by way of a share sale by HSBC UK Bank Plc.  The CMS UK team has produced an updated FAQ to answer some of the key questions, including those that we have been hearing from our own clients. You can find this here.   As always, please do not hesitate to contact your client relationship partner at CMS if you have any questions about how this affects you and your business. Additionally, we’ve also set up a dedicated support email ad­dress help2023@cmsleg­al. com to contact us if you need assistance.

Munich – German fibre network operator Sewikom has been acquired by infrastructure company Northern Fiber Holding GmbH. The latter is part of UBS Asset Management Real Estate & Private Markets (UBS-AM)...

Uncertain times, an evolving legal framework: managing risks and ensuring social responsibility in the life sciences & healthcare sector The risks of AI in the future of life sciences will come under the microscope at a landmark legal forum this week. Healthcare is racing ahead in adopting new technologies across drug discovery, development, manufacturing and supply chain but experts predict a tail-whip of disputes and contract friction. Digital transformation has the potential to improve every aspect of healthcare and the pharma industry but it also impacts data protection, IT security, contract design, liability and regulation. The annual CMS Global Life Sciences and Healthcare Forum will bring together high-level industry and legal experts to discuss sector intelligence and best practice as well as issues ranging from cyber breaches and cryptocurrency wrangles to fall-outs over trade secrets and intellectual property (IP).“AI offers amazing opportunities to advance life sciences and usher in transformative medicine such as cell and gene therapy, improved diagnostics and analytics but it also comes with concerns as legal and contractual risks are still being understood and evaluated,” says Nick Beckett, Global Co-Head of CMS Life Sciences & Healthcare Sector Group“Science and technology are moving forward very quickly but we are finding that the detail and strategy of what to do to mitigate risks or resolve them is lagging behind. These are critically important issues that companies need to address and the Forum will examine the implications and solutions.”AI is booming and a recent report by analysts  Grand View Research forecast that the global AI in healthcare market will grow from its current value of $10.4 billion at a compound annual growth rate (CAGR) of 38.4% from 2022 to 2030. AI is fast becoming a significant element of every aspect of healthcare and legal departments and business units are being challenged to respond. The Forum, which is being held in Brussels and online on Thursday, September 28, has a packed agenda covering technology transformation, Environmental, Sustainability and Governance, supply chain disruption, regulatory frameworks and the changing commercial landscape. The scale of challenge was evidenced in the recent CMS Technology Transformation: Managing Risks in a Changing Landscape report which revealed that 56% of corporate counsel and risk managers expect an increase in AI-related disputes, while 50% believe that the use of AI technologies will lead to risks and disputes that cannot currently be foreseen. Disputes will be driven by issues arising from IP and trade secrets, the use of AI, smart contracts, cryptocurrencies and cloud services, they be­lieve. “Or­gan­isa­tions are likely to see new types of risks and disputes emerge from the use of new technologies such as AI and crypto­cur­ren­cies. Many businesses are playing catch-up in understanding the risks associated with these new technologies,” says Lee Gluyas, Partner, CMS. “Whilst no business can eliminate risks completely, those that think ahead, plan early and actively manage risk will give themselves a substantial ad­vant­age.” The free to attend Forum will feature keynote speakers from the United Nations Health and Development Team, general counsel from leading pharma companies, Boston Consulting Group, financial services multinational Aon and CMS sector specialists. For further details or to attend, register here: https://cms. law/en/int/events/glob­al-life-sci­ences-health­care-for­um-2022.

Cologne – Frankfurt-based data centre operator maincubes has gained Digital Transformation Capital Partners (DTCP) as a new strategic investor with a focus on digital infrastructure. DTCP made a substantial...