Category Archives: Data protection

Do You Have Records Management Problems?

If you look through my blog posts and LinkedIn updates over recent years, you’ll be forgiven for thinking that all I do is support pharmaceutical companies with their trial master files (TMFs). It is true that this has taken up … Continue reading

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US Safe Harbor Scheme Ruled Invalid

The Court of Justice of the European Union today ruled that the European Commission’s decision that the US Safe Harbour scheme provides an adequate level of protection is invalid. Their ruling states: “In the light of the revelations made in … Continue reading

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Retention Scheduling? Don’t Forget Data Protection Laws!

Research recently conducted by PwC on behalf of Iron Mountain suggests that more than a third (35%) of small European companies are risking prosecution by “hoarding” data beyond the scope and period required by data protection legislation. When these companies were … Continue reading

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Should Clinical Trial Data be Excluded from Data Protection Act Requirements?

Let’s start off the week with a controversional question! A Code of Practice released by the UK Information Commissions Office on 20 November adds an interesting slant to the question. The Code of Practice (Anonymisation: Managing Data Protection Risk) reconfirms that … Continue reading

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Should Clinical Trial Data be Regarded as Personal Data?

This question has been discussed heavily since the issue of the EU Data Protection Directive 95/46/EC back in October 1995. Over the years, there has been a concensus of opinion that patient records should be regarded as coming within the … Continue reading

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