Legal and Regulatory Compliance

Correct Answer: GDPR

The General Data Protection Regulation (GDPR) is the most stringent data protection regulation that requires prompt notification of data breaches. Under GDPR, organizations must report a data breach to the supervisory authority as soon as possible, and at the latest within 72 hours of becoming aware of the breach. If the breach is likely to result in a high risk to the rights and freedoms of individuals, the organization must also inform the affected individuals as quickly as possible. This requirement for swift action and transparency makes GDPR the most relevant regulation for the scenario described in the question.

Correct Answer: Establish a business associate agreement (BAA) with the third-party provider.

The most critical step the pharmaceutical company should take to ensure the arrangement with the third-party logistics provider complies with HIPAA regulations is to establish a business associate agreement (BAA) with the third-party provider. A business associate agreement is a legal contract that outlines the responsibilities and obligations of the third-party provider (the business associate) in handling and protecting the sensitive customer medical information on behalf of the pharmaceutical company (the covered entity). The BAA ensures that the business associate adheres to the same privacy and security standards as required by HIPAA. The other options, while important, are not as critical as establishing a BAA: - Preparing an inventory of customer data is useful for understanding the scope of information shared but does not ensure compliance. - Implementing a security awareness program and providing training about privacy regulations are valuable steps but do not legally bind the third-party provider to HIPAA compliance. - Conducting background checks on the third-party provider's employees helps mitigate risks but does not guarantee HIPAA compliance. - Disabling physical access to the storage facility enhances security but is not the most critical aspect of HIPAA compliance in this context.

Correct Answer: EU-US Privacy Shield

The EU-US Privacy Shield is a GDPR-approved mechanism for data transfers between the EU and the US. The Swiss-US Privacy Shield covers data transfers between Switzerland and the US. International Safe Harbor Privacy Principles were replaced by Privacy Shield in 2016. Schrems II is an EU court case that invalidated the EU-US Privacy Shield but may still influence data transfer mechanisms. BCR and SCC are alternatives but not specific to EU-US data transfers.