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Milo Assessment of GDPR

Milo Assessment of GDPR and HIPAA Compliance 

 

GDPR Compliance  

Relevant articles of the GDPR 

Implementation 

Territorial Scope 

Article 3 

Customers have the option of hosting data in Data Centers located in The FRance, US, UK or Australia. For European trials, this means that medical data will not be transferred outside of the EU. 

 

Principles relating to processing of personal data. Employee awareness training 

Article 5 

Personal data of Milo Employees is collected solely to support their work at Milo. For Customers, personal data is collected solely to support and improve their interactions with Milo.  

This primarily requires each contact’s full name, username, title/role, email address, phone number and job responsibilities. For Patients, the entry and use of personal data is the responsibility of the Customer. Milo provides secure hosting of the applications and corresponding databases.  

Only limited personnel within Milo have access to production databases based on their role. Authorizations are granted on the ‘need to know’ and ‘least privilege’ principles. These access restrictions are described in SOPs. All employees are aware of commitment to protecting patient information and are properly trained in Data Privacy, GDPR, and HIPAA. 

Lawfulness of processing 

Article 6 

Milo performs no processing of personal data other than is necessary to manage its Employees, support its Customers, respond to prospective Customers and fulfill its obligations to manage clinical trial data based on contractual requirements with Customers. 

 

Conditions applicable to child’s consent 

Article 8 

Milo assumes that, for Patients in pediatric trials, informed consent is signed by the child’s authorized representative. Therefore no additional provisions are required for a child’s consent. Ultimately, this is the responsibility of the Customer. 

 

Processing of special categories of personal data 

Article 9 

No such personal data is collected directly from Customers by Milo. For Patients, where medical, genetic or biometric data can be collected, Milo assumes condition 2(a) of Article 9 applies. i.e., the patient has given explicit informed consent. Data is protected using technical and organizational security measures. 

 

Privacy Statement 

Article 5, 12, 13, 14 and 15 

By visiting Milo’s websites and by using its services, website visitors and Customers are trusting Milo with their personal data. In the privacy and cookie statement Milo explains which data it collects and for which purposes. See Milo Privacy and Cookie Statement. 

 

 

Data Portability 

Article 20 

Participants of investigational studies must request data through Investigator, Sponsor, or CRO. Data Controller will contact Milo with any requests. Milo has a documented procedure in place to carefully handle these specific requests. Our “Data Subject Request Procedure” describes this process. It can be reviewed during audits. 

Data Retention Policy 

Article 5, 13, 17 and 30 

Milo documents its data retention policy in a processing activities registry according to article 30 GDPR. Patient data is retained in Milo’s databases 25 years after study is completed or sooner upon Customer’s request. Milo’s “Document management and retention policy” can be reviewed during audits 

 

Security of processing 

Article 5, 18 and 32 

Integrity and honesty are the key attributes of everything we do at Milo. We are committed to protecting our customers’ data above all else. Milo is secured according to the most recent standards in order to protect your data in the best possible way. See Milo Security Statement. 

 

Appointment of DPO 

Article 37-39 

Milo has appointed an external DPO in order to comply with the obligations under the GDPR. 

 

Data Subject Rights Policy 

Article 15-23 

Milo has a documented procedure in place to carefully handle these specific requests. Our “Data Subject Request Procedure” describes this process. It can be reviewed during audits. 

 

Responsibility of the Controller 

Article 24,28 

Milo is the controller of Employee data, and the processor of Patient data. Appropriate SOPs and security measures have been put in place to ensure correct organizational processes are followed when collecting and handling personal data. Security measures and the associated tools for managing security are outlined in more detail in Milo’s “Information Security Policy”, which can be accessed during audits. General Information disclosed in Milo Security Statement. 

 

Privacy by design and by default 

Article 25 

“Secure Development & Quality Assurance Policy” and “Security/Privacy by Design Checklist” describe how these measures are implemented. Authorizations to internal environments and systems are granted on the ‘need to know’ and ‘least privilege’ principles. 

 

Data Processing Agreement (Milo customers) Engaging Sub Processors 

Article 28 

Milo’s obligations towards its Customers is covered under the Master Service Agreement “Milo Healthcare SAS”. Milo also maintains a Supplier procedure that includes the completion of a DPA. 

 

 

 

 

 

Data Processing Agreement (Suppliers – Milo as Controller) 

Article 24 and 28 

Milo has a specific procedure in place to make sure products and services are purchased with suppliers who comply with Milo’s selection criteria and are onboarded according to Milo requirements (including the correct documentation), both to make sure all purchased products and services comply with the quality and information security standards needed for Milo. All details are covered under Data Processing Agreements. 

 

Data Processing Agreement (Suppliers – Milo as Sub-Processor) 

Article 28 

Milo has a specific procedure in place to make sure products and services are purchased with suppliers who comply with Milo’s selection criteria and are onboarded according to Milo requirements (including the correct documentation), both to make sure all purchased products and services comply with the quality and information security standards needed for Milo. Covered under Data Processing Agreement. 

 

Records of processing activities 

Article 30 

Documented in “Milo GDPR – Processing Activity Register” For Patients, the sponsor or CRO is responsible for the obligations set out in paragraph 1 of Article 30 as the controller. For Milo Customers, under paragraph 2, Milo only performs processing based on a signed Work Order or Change Request as the processor. MSA’s and DPA’s include details of processing activities and sub-processors. 

 

Data breach procedure 

Article 28, 33 and 34 

If a data breach poses a risk to an individual’s rights and freedoms, Milo has a “Personal Data Breach management procedure” in place to notify the supervisory authority without undue delay, and at the latest within 72 hours after having become aware of the breach. If Milo operates as a data processor it will notify every data breach to its Customer(s) within 48 hours. 

 

Cooperation with the supervisory authority 

Article 31 

Milo has an established process for supporting a regulatory inspection. 

 

Records of (possible) data breaches 

Article 33 

Milo has an overview of all (possible) security incidents and data breaches, managed through a CAPA List in Legis way 

 

Privacy Impact Assessment 

Article 35 

A Data Protection Impact Assessment (DPIA) is a process that helps Milo identify and minimise the data protection risks of a particular service or product. Milo will perform a DPIA if type of processing is likely to result in a high risk to individuals. 

 

Safeguards and derogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes 

Article 89 

General information disclosed in Milo Security Statement 

 

 

 

Milo HIPAA Compliance  

Milo ensures compliance with HIPAA requirements through:  

  • Awareness Training to all employees  
  • Establishment of data and privacy policies and procedures, including Data Breach Policy  
  • Risk Analysis and Management to track access of PHI  
  • Administrative Safeguards: Security Management, Security Training, Information Access Management  
  • Technical safeguards to protect access to data 
  • Data Integrity Controls  
  • Periodic reviews and Internal Audits to evaluate the effectiveness of security measures  
  • Establishment of Privacy Officer