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923Hz | Cybersecurity regulation ain't for the faint of hearts. #MDR

The most important digital health regulation out of 2023 is the European Union's Medical Device Regulation (MDR), which came into force on May 26, 2021. The MDR is a significant update to the previous EU medical device regulation, and it introduces a number of new requirements for digital health companies.

One of the most important new requirements is that all digital health products must now be classified according to their risk level, and they must be tested and certified accordingly. This means that digital health products that pose a higher risk to patients will be subject to more stringent regulatory requirements.

The MDR also includes new requirements for data privacy and cybersecurity. Digital health companies must now have robust data privacy and cybersecurity policies in place, and they must take steps to protect patient data from unauthorized access or use.

The MDR is a significant development for the digital health industry, and it is likely to have a major impact on how digital health products are developed and marketed in the EU.

Other important digital health regulations that came into effect in 2023 include:

  • The UK Medical Devices Regulations (MDR), which is the UK's implementation of the EU MDR.

  • The Virginia Consumer Data Protection Act (CDPA), which is the most recent state-level data privacy law to come into effect in the US.

  • The EU's Network and Information Security 2 Directive (NIS 2), which implements security and reporting requirements across EU states.

More to come on the regulations above.

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