An MTA governs the transfer of tangible research materials between organizations. This playbook highlights confidentiality, permitted use, and ownership of resulting data or inventions.
Why This Matters: Insufficient data security can lead to regulatory penalties, data breaches, and loss of patient trust.
Negotiation strategy
If you're the Provider:
Ensure that all data protection measures are clearly defined and compliant with industry standards. Negotiate for regular audits and assessments to verify compliance.
If you're the Recipient:
Propose reasonable data protection measures that align with current capabilities. Ensure that breach notification timelines are feasible and clearly outlined.
Essential elements
1
Data Protection Measures
Technical and organizational safeguards.
2
Breach Notification
Timely reporting of data breaches.
3
HIPAA Compliance
Adherence to HIPAA regulations.
Action framework
ACCEPT
Propose edits if existing measures lack specificity or fail to meet industry standards.
EDIT
Reject clauses that do not ensure adequate protection or compliance with legal requirements.
ADD
Add clauses to address any missing data protection or compliance elements.
PRO TIP
Regularly review and update data protection measures to align with evolving legal standards and technological advancements.
Example clauses
FAVORABLE
Preferred Data Protection Measures
"The parties agree to implement and maintain appropriate technical and organizational measures to protect the security, confidentiality, and integrity of protected health information and other sensitive data. These measures shall include, but are not limited to, encryption, access controls, and regular security assessments."
NEUTRAL
Standard Data Protection Clause
"The parties shall implement reasonable measures to protect sensitive data."
UNFAVORABLE
Inadequate Data Protection
"The parties will attempt to protect data as best as they can."
Fallbacks
High-Risk Projects
For projects involving high-risk data, additional security measures and stricter compliance checks are necessary to mitigate potential breaches.
Cross-Border Data Transfers
When data is transferred across borders, ensure compliance with international data protection laws such as GDPR.
Cloud Storage Solutions
Utilize cloud storage solutions that offer robust security features and comply with relevant data protection regulations.
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