Law in MedTech and Telemedicine. MedTech – responsibility in times of innovation
The MedTech industry is inextricably linked to responsibility. On the one hand, for the health and lives of patients – on the other hand, for the extremely sensitive information about those patients .
Entities in this industry cannot afford the slightest lapses in the regulation of their business or patient rights. Hence, a responsible approach to the law is fundamental.
At dotlaw – for our MedTech partners – we bring order and a stable legal structure. As a result, organizations achieve a responsible approach to all regulations.
Our partners we have worked with in the MedTech industry:
Competitive advantage in the MedTech industry
Just like in any other industry – technology provides a colossal increase in business efficiency. What is unique about the MedTech industry, however, is that mistakes and errors in technology implementation are far more costly than in other industries.
How do you build a competitive advantage under these conditions?
Offering more maturity and stability than competitors. Through maturity and stability, B2C businesses in the MedTech industry build a responsible brand image among consumers. B2B businesses, on the other hand, increase their value in the eyes of contractors thanks to maturity and stability.
Paradoxically – the traditional approach to law is a huge obstacle to business maturity and stability.
On the one hand, the traditional approach to law – each legal regulation is treated separately, in isolation from other regulations. On the other hand, the traditional approach to law is based on artificial and uncommunicative language.
In the traditional approach to law:
1
The pace of change in technology and the industry’s regulatory pace that follows it require regular and rapid responses from players. A unitary approach to regulation prevents preparation for the future.
2
Dozens of contradictory internal regulations – often created just to formally fulfill a legal obligation – make it impossible to act effectively in emergency situations.
3
Moreover – the internal legal mess resulting from such a strategy makes it impossible to obtain various certifications that build trust in the market (for example, ISO certification).
4
Dozens of pages of contracts for contractors – understandable only to lawyers – not only prevent the quick and safe acquisition of new clients – they often obscure for both parties the exact terms of the agreement.
The traditional approach to the law is a law disconnected from life.
What if legal solutions served to introduce technology instead of preventing it?
Traditional approach to law
The law of the digital revolution era
dotlaw for the MedTech industry
Understanding the challenges of the MedTech industry – we base our services on four pillars:
Practicality
Successful legal solutions must carefully address your challenges and move your business forward whenever possible.
Describing abstract legal risks is not enough! We are always looking for solutions.
Full transparency
There will be no fruitful cooperation without full trust.
On our side, we understand that this means full transparency in the relationship with you.
Modern working methods
If legal solutions are to be tailored to your unique challenges – they must be created with you! That’s why we work through modern tools: Slack, Asana and Google Docs.
Plain Language
All our activities are based on the best practices of legal design. This ensures that the language remains understandable – further fully securing your business legally.
Our specialists in the MedTech industry
Typical projects in the MedTech industry that we implement:
- Establishment and registration of a treatment entity;
- Creation of internal documentation of the treatment entity;
- Preparation of opinions and analyses in the field of medical law, including opinions on the qualification of a product as a medical device;
- Strategic corporate consulting, regulation of relations between group companies;
- Creation and negotiation of contracts related to the conduct of medical activities;
- Legal support in the development of healthcare-related IT products;
- RODO audits, implementation and training.
However, we will take on almost any challenge in the MedTech industry – contact us!