Overview
Cutting-edge technologies are transforming the Health Sector, including the doctor-patient relationship and the illness prevention, diagnosis and treatment cycle. Artificial intelligence, robotics, Big Data, 5G and the Internet of Medical Things (IoMT), are all bringing more efficiency, automation, personalization and connectivity to the Health Sector. Biotechnology and nanotechnology offer promising solutions for both diagnosis and treatment of diseases in terms of medicines and medical devices. Technology plays a central role in the prevention and fight against epidemics and pandemics.
Trends
The Health Sector is undergoing a digital transformation process reflected in the development of more advanced technologies for the prevention, diagnosis and treatment of illnesses and in the development of technologies and services to bring doctors and patients closer together and enable real-time patient monitoring.
Artificial intelligence and Big Data are increasingly used to establish logical connections between health data, as well as for data predictive analysis and interpretation, revolutionising the efficiency and accuracy of diagnosis or enabling the identification of more effective treatments. Artificial intelligence also streamlines the development of new medicines and medical devices and the performance of clinical trials.
Through connected and network-connected medical devices (software connected to portable devices, wearables, ingestible or embedded medical devices) the IoMT is creating new patient-health care professional synergies and revolutionising the way in which patients' health status is monitored and followed up, creating unparalleled opportunities in the field of telemedicine and remote treatment.
Robotics and nanotechnology introduced the use of microbots and microdevices to assist in the diagnosis and the performance of cutting-edge surgical procedures.
The use of technology in the field of biomedicine has also allowed the development of technologies with great impact on human genome editing, cell therapy, regenerative medicine and the development of new generation medicines.
Legal Challenges
New legal and regulatory challenges arise from the increasing digitalisation, personalization, automation and connectivity in the Health sector:
Applicable standards and regulatory requirements, research partnerships, protection of innovation, intellectual property and trade secrets, collection and analysis of Big Data.
Analysis, evaluation, testing, registration and other requirements applicable to the marketing of new technologies (especially in such pioneering matters as the use of software as a medical device, medical devices with artificial intelligence, health Apps), technology’s compliance with the rules for data processing and sharing, platforms and partnerships for testing and pilot projects.
Compliance with legal rules and requirements regarding the introduction of medicinal products for human use and the marketing and sale of medical devices, as well as legal rules applicable to the provision of healthcare services, use of biological material and/or nanomaterials, insurance and liability for defective products, misdiagnosis, malfunctioning medical devices, health technology connectivity issues or negative outcomes.
The demand for more personalized healthcare in line with technological development poses new legal and regulatory challenges in the health sector, including with regard to clinical and scientific research and the development of new medical technologies.
- Regulatory, Standards & Compliance
- Technology integration and updates
- IP & Trade Secrets
- Insurance & Liability
- Data (personal and non-personal) & Cybersecurity
- Procurement / public-private synergies
- R&D of new technologies
Step-by-step
What?
Forces driving the market
Patient-focused treatments based on precision medicine customised to the patients’ needs.
Use of bionic limbs, bots and microbots, exoskeletons, tools and robots to support surgical procedures.
Use of own network infrastructures and data architectures, through the use of cloud tools and private 5G networks.
Processing large amounts of data using AI for a more efficient and prompter research, diagnosis and treatment of illnesses and medical decision-making.
Nano drugs, biological medicines and medicines containing genetically modified organisms (GMOs), as well as the development of nanotechnology and the use of biological material (such as stem cells).
How?
Can we help you
VdA has vast experience and strong expertise in all policy, legal and regulatory matters associated with Health Tech. Our tech and industry insights of the Health Sector and its main players allow us to provide 360.º legal services to organisations, governments and regulators.
- Healthcare providers (Hospitals, Clinics)
- Pharmaceutical companies
- Clinical pathology or clinical analysis labs
- Medical devices and equipment developers and suppliers
- Technology developers and suppliers
- Health hubs/labs/incubators/think tanks/ research centres
- Telecommunications operators
- Insurers
- Public institutes and foundations
Our team of experts is delivering strategic legal advice to help our Clients on their most challenging and promising projects. With a track-record of advising complex projects for leading Health companies as well as for the public sector, VdA services include:
Private sector:
- Advising on regulatory and compliance issues for testing, developing and marketing of new health technologies and the provision of healthcare services, including research, marketing, manufacturing, distribution and sale of medicines and medical devices
- Advising on liability & insurance issues, personal data protection and cybersecurity, IP and technology transfer
- Drafting and negotiating contracts for development and sale of medicine, medical devices and the provision of healthcare services
- Assisting in connection with the clinical research or technology development stages, including compliance by design and compliance by default related matters and monitoring all stages of the value chain
- Advising on communication and coordination with public entities and regulators
Public sector:
- Drafting policies, strategies, laws and plans relating to health and technology issues, including pilot projects or on new technology research related matters.
- Advising on public contracts, public-private partnerships, pre-contractual proceedings and public tenders
- Negotiating partnerships and memoranda of understanding with governments, institutions, organizations and private sector players
- Advising on the outline of innovation support programmes in the health sector and knowledge and entrepreneurship ecosystems or platforms (start-ups, SMEs, incubators and accelerators)
Our Tech Health Roadmap Product
Tech Health Fitness Check and Guidance is a turnkey set of services that integrates several modules our clients can choose from in accordance with their needs.
- Contract Programme
- Regulatory & Compliance
- IP & Trade secrets
- Data (personal and non-personal) & Cybersecurity
Our team of experts
The disruption of the Health Tech ecosystem raises complex challenges that require a 360º holistic and sophisticated legal analysis.
We help our clients meet their goals through a cross-sector team that brings lawyers from our ICT, Health, PI, Public Procurement and M&A Practice Areas. In addition, our team further works routinely with our colleagues from Tax, Insurance, Banking & Finance, Competition, Infrastructures, Energy & Natural Resources, among others.
Why?
Specialised knowledge is required
The opportunities and challenges of the Health Tech sector, including those arising from the deployment of new technologies, are complex. VdA is especially knowledgeable of the opportunities, challenges and legal and regulatory frameworks applicable to the Sector in Europe and in Africa.
The anticipated ageing of the population (according to the EU eHealth Task Force, the percentage of the European population over 60 will almost double by 2060), the decline in the working-age population, the demands for a more personalised medicine and the risks of epidemics and pandemics, require Member States' health systems to adapt to realities shaped by changeability and fast-paced technological advances.
The objectives set by the European Commission through strategic plans such as the EU Health Programme and its Annual Work Plans, namely the promotion of effective, efficient and resilient health systems, as well as the increased access to healthcare services and the upgrade of health care facilities, create unique opportunities for the sector supported by funding mechanisms and initiatives such as Horizon Europe 2021 - 2027, Innovation Union and the Digital Agenda for Europe. To address the new challenges in the health sector, the European Commission has also launched the Pharmaceutical Strategy for Europe, a framework that promotes research and development of affordable and effective technologies.
VdA has a strong know-how regarding the legal requirements applicable to the Health sector and is well positioned to support its clients in their innovative projects, by immediately tackling the regulatory challenges at hand. VdA has extensive experience in defining strategies and creating solutions for the development, testing and marketing of health technologies and the provision of healthcare services, including AI-powered medical devices and medical software, as well as medical robotics, IoT and eHealth.
VdA also has relevant know-how regarding Health Tech critical matters, including intellectual property, cybersecurity, data protection, liability, insurance and connectivity, according to the latest European Union’s policies, strategies, legal provisions and regulations.
Africa is facing structural challenges in the Health Sector related to shortages in health systems, medical care and human workforce, and logistical and bureaucratic difficulties in the acquisition and transport of medicines, among others. According to the World Health Organization (WHO), 79% of the pharmaceutical products used in Africa are imported. This widespread lack of access to medicines is a determining factor in the escalation and spread of malaria, tuberculosis and the HIV/AIDS virus.
Despite these shortages, various initiatives are being developed to improve the sector. The goals set by the African Union in the strategy set out in the AHS 2016–2030 (“African Health Strategy”), based on the “Agenda 2063: The Africa We Want”, seek to address the continent's health challenges, including by improving the performance of the health systems and increasing the investment in the health sector. The African Health Strategy prioritises the development of the African health sector in order to meet the global and continental commitments undertaken in several instruments and strategic plans, such as the "Maputo Plan of Action 2016-2030" and the "Pharmaceutical Manufacturing Plan for Africa”. The WHO’s Health Technologies and Innovations Programme for Africa already includes the access to and the reasonable use of health technologies among its goals, noting that these matters should be addressed in the national policies of African countries.
VdA and VdA Legal Partners have relevant experience in advising Governments, regulators and international organizations in connection with innovative Health tech projects. VdA also has relevant experience in advising companies in connection with the design, development and testing of Health Tech products, as well as with the research, marketing and sale of medicines and medical devices and the provision of technology-based health care services. VdA also has experience in the use of technology and data for disease identification, control and mitigation, according to the applicable rules on data protection, cybersecurity, connectivity and network infrastructures, intellectual property and IoT.
When?
Can we do it for you
Assisting you in devising the best approach and models for your business, project, product and/or service, in the light of legal and regulatory opportunities and constraints.
Assisting you in the development and setting-up of your business, project, product and/or service, drafting all required documentation, assisting in the negotiation of contracts, interacting with competent authorities and accompanying you every step of the way.
Assisting you in addressing day-to-day business goals and challenges in the light of the applicable laws and regulations. We are here for you.