There have been a few updates surrounding the world of transparency recently and we have also witnessed a landmark decision being made in relation to data privacy. Our July edition of the LegalEZ Compliance Digest digs deep and provides you with detailed information which will be beneficial all.

Applications are currently being made for the Massachusetts License Application Renewal. This applies to pharmaceutical and medical device manufacturing companies that employs a person to sell or market prescription drugs or medical devices. Make sure your applications are in before the deadline of 31st August with a fee of $2,000.

For those who have been eagerly awaiting the CMS Program Year 2022 data to be published, need not wait any longer. The data is now live and can be accessed on the CMS website. For Program Year 2022, CMS published $12.59 billion in payments and ownership and investment interests. Covered recipients still have until December 31, 2023, to review and affirm, or, if necessary, dispute, records attributed to them that were submitted in Calendar Year 2023.

Transparency reporting can be a daunting process, so we have given you a helping hand and provided you with a sample US Data Collection Guide. This of course can be used for global reporting and tailored to meet the requirements of the country.

We previously spoke about the Nevada Senate Bill 203 Bill which prohibited certain gifts by a manufacturer or wholesaler of drugs or medical devices to a practitioner. These measures were not enacted by the Nevada Legislature and therefore, the transparency reporting requirements remain the same.

The amendments to the California Consumer Privacy Act (CCPA) under the California Privacy Rights Act (CPRA) have now come into force. The Act toughens some requirements of the (CCPA). It should be noted that the CPRA amends the CCPA and is not itself a new law. The CPRA does not repeal or replace CCPA but strengthens the existing framework in key areas. Businesses dealing with California citizens sensitive personal data should check to see if they are affected by the amendments and if so, they are strongly encouraged to ensure their existing policies are reviewed in line with the new amendments.

Moving across the pond, we have France transparency reporting deadline due on 1st September and monthly deadlines for Portugal and Indonesia. EFPIA have interestingly created a European Gateway Map, on their website, which provides access to the publicly available data disclosed by member companies.

MedTech has issued a new Manufacturer’s Declaration in relation to Regulation (EU) 2023/607 which companies can use or adapt. The updated Luxembourg Code of Ethics is now available on the IML website. This is only currently available in French but the association is working on providing an English translated copy.

Data Privacy is high on everyone’s agenda, especially with more and more states in the US introducing some form of Data Privacy laws. The EU GDPR has been a hot topic for some time now especially after the EU ruling of EU-US Privacy Shield not providing adequate protection. There has been a breakthrough and The European Commission has now adopted a new adequacy decision for the EU-U.S. Data Privacy Framework. The European Commission has decided that under the new framework, the United States provides an adequate level of protection comparable to that of the European Union. This Adequacy Decision offers companies an additional mechanism to legitimize the companies’ data transfers from EU to USA.

The Italian Sunshine Act has kept us on our toes since it was made in to law in May 2022. There is still no update on the Telematic Public Register, which the Ministry of Health should have implemented in January 2023. With many individuals being a little clueless on what is going on, we have outlined key differences between the new and old rules around the Italian Sunshine Act.

A little heavy with our updates this month, but we are confident you will have a good read!