Digital Health Study Notes DFGSM2 2023-2024

• This document contains study notes on digital health topics for DFGSM2 in 2023-2024.

Data of Health

• Personal data is information relating to an identified or identifiable individual, directly or indirectly.
• Sensitive data is a special category of personal data, revealing racial origin, political opinions, religious beliefs, health information, etc.
• The use or collection of sensitive data is prohibited by the GDPR, unless explicit consent is given, the data has been made public, or it is necessary to safeguard human life.
• Health data includes information relating to the physical or mental health of a person, including healthcare services.
• Health data is considered sensitive and requires special protection.
• It's important to distinguish between anonymous, pseudonymized, and directly identifiable data.

Types of Health Data

• Data by nature: Information directly related to health status, such as diagnoses and treatments.
• Data by combination: Data that becomes health-related through association.
• Data by destination: Information used in a medical context for health assessment.
• Data connected for personal use without external sharing is not considered health data by regulation.

Levels of Identifiable Data

• Directly identifiable data: Information that allows immediate identification of a person.
• Indirectly identifiable data: Information that can lead to identification.
• Pseudonymized data: Transformed personal information, not attributable to a specific person without additional information, replacing directly identifying with indirectly identifying data.
• Anonymous data: Processed to make individual identification impossible, rendered irreversible, and no longer considered personal data.
• Aggregated data: Has the lowest level of identification.

Anonymization

• A definition: Process transforming personal data to prevent individual identification through randomization and generalization techniques
• Randomization modifies data to reduce precision while preserving statistical integrity
• Generalization increases the level of data generality to avoid individual ID
• Evaluation of anonymization requires meeting individualization, correlation, and inference criteria to reduce re-identification risks.

Legal Framework for Data Protection

• LIL: French law adopted in 1978, regulates personal data processing, establishes individual rights, and created the CNIL.
• RGPD: Applicable since May 2018, a European law to strengthen and unify data protection for all individuals within the EU, applies to any org that processes personal data of European residents.

Data Protection Principles

• Transparency requires informing individuals about data collection and use.
• Purpose limitation restricts data collection to explicit, legitimate objectives.
• Data minimization requires collecting only data necessary for specified objectives.
• Accuracy requires data to be accurate and up-to-date.
• Retention limitation restricts data to be kept only as long as necessary.
• Integrity and confidentiality require secure data handling.

Data Processing

• Data processing is generally prohibited by LIL and RGPD, with exceptions.

Regulatory Framework

• The RGPD applies if the data controller is in the EU or if the data concerns people in the EU.
• LIL applies to all personal data processing by entities in France.
• CNIL is an independent administrative authority responsible for ensuring data privacy and freedom, with missions to inform, protect rights, support compliance, anticipate, innovate, control and sanction.
• The CNIL enforces the RGPD in France.

Patient Rights

• These are "legal bases" as proposed by the RGPD, they grant a right for an organization to process personal data, including consent, contract, legal obligation, public interest mission, legitimate interest, and safeguarding vital interests.
• Individuals have right of access to know what personal data is processed and to obtain a copy.
• Right to rectification allows patients to request correction of inaccurate data.
• Right to erasure allows patients to request the deletion of their data.
• Right to restriction of processing allows patients to limit the processing of their data.
• Right to data portability enables patients to receive their personal data in a structured format and transmit it to another controller.
• Right to object allows patients to oppose the processing of their data in some circumstances.

Data Processing Definition

• Data processing includes any operation performed on personal data, such as collection, recording, organization, structuring, storage, adaptation, modification, extraction, consultation, use, communication, dissemination, alignment, combination, restriction, erasure, or destruction.
• Each data processing action must comply with regulations, especially the RGPD.

Consent

• A definition: Consent must be a freely given, specific, informed, and unambiguous indication of the data subject's agreement to the processing of personal data relating to him or her
• Conditions are free, specific, informed, and unambiguous.
• Consent is one of the six legal bases provided by the RGPD.

Data Processing Stakeholders

• The Data Controller determines the purposes and means of the data processing.
• The Data Processor processes data on behalf of the controller.
• The Data Protection Officer oversees compliance with the RGPD, advises the organization and employees, and acts as a contact point with the CNIL.
• The RT is primarily responsible for compliance, demonstrating it through accountability.
• The DPO plays a crucial role in ensuring compliance and raising awareness.
• The Principle of Accountability obliges the RT to demonstrate compliance.

Key Measures

• Maintain a register of processing activities to have a clear view of all data processing operations.
• Carry out Data Protection Impact Assessments for high data processing risk, helping to identify and minimize risks.
• Ensure clear communication with data subjects, providing information and facilitating the exercise of their rights.
• Define roles and responsibilities of the RT and data processors for effective data management.
• Implement security measures to protect data against unauthorized access, loss, or destruction.
• Appoint a DPO to oversee RGPD compliance.

Implementing a Health Data Processing System

• Define the purpose and ensure it is legitimate, explicit, and determined.
• Identify the legal basis justifying the processing.
• Understand derogation conditions for data collection.
• Ensure collected data are adequate, relevant, and limited to what is necessary.
• Verify that data are accurate and up-to-date.
• Inform patients and provide the opportunity to exercise their rights.
• Implement technical and organizational measures to protect data, ensuring integrity and confidentiality.
• Adapt the retention period to the purpose of the processing and maintain data quality.
• Verify compliance with approved CNIL standards and document all aspects of processing.

Health Research

• The following are the objectives: Alleviating the formalities for data processing in health research.
• The methodologies of reference include RIPH, RNIPH, and MR, for example
• If methodologies are conformed with, CNIL authorization isn't needed.
• Non-compliance requires an authorization request or file deposit.

Consequences of a Sanction

• Obligation to inform the CNIL may arise from an issue of data security.
• Risks include fines for a security or information shortcomings.
• Risks include disciplinary or criminal punishments for data copies.

Key Takeaways

• Any operation on personal data constitutes data processing.
• The RT and the DPO are crucial in data processing.
• Valid patient consent must be uninhibited, specific, enlightened, and unequivocal.
• Consent includes a withdrawal right.
• Document all personal data processing activities in the institution by the RT.

Healthcare

• Process to ensure the singularity of each user in healthcare to avoid identification errors
• Identification and Authentication requires a knowledge of identity.
• Authentication requires two entities: a prover and a verifier.
• Classic procedure involves enrollment, identification, and authentication to prove one's identity.

Authentication Factor Categories

• Knowledge factor: what I know
• Possession factor: what I possesses
• Inherent factor: biometric characteristics
• Multifactor authentication: Combining several factors, one from each category.
• Strong authentication: relying on a cryptography mechanism

Pro Santé Connect

• Functions: It's a standard for supplying an OpenID identification, ensuring strong authentication for healthcare professionals using e-healthcare services.

National Health Identifier (INS)

• Resolves identitovigilance challenges
• Comprises 5 identity traits and matricule
• Matricule from the national database
• The INS must be assessed for data validity.

National Directory of Health Professionals

• Establishes trust and is essential for digital tools used in health
• Referencing a unique number for all people acting in health ensures secure access to data.
• Holds ID information like name, profession, contact details, and is verifiable through ADELI and RPPS
• Managed by the ANS to assure the content within the healthcare directory.

Digital Health Tools for Communication

• The Maison e-Santé illustrates France's strategies with ethics, security, and communication
• The MSSanté secures data and offers interoperability
• The MSS-C secures communication for citizens of healthcare settings.

Interacting with Users

• Safe and efficient messaging for a transparent communication
• Includes an internal health directory
• Types of inboxes contain nominative, organizational, and application structures.

Sharing Healthcare Data Responsibly

• Securing data to share and integrate
• Gaining consent of users to protect their data

Key points

• These standards are a foundation of e-healthcare for France and will connect health workers.
• Securing data and working together to safely connect people with technology.

My Health Space Origination

• Strategies to enhance digital health in France by implementing values
• Goals for managing health include better communication and a singular approach to managing health.
• MSS-C is a digital messaging to increase interoperability

Medical Profile Basics

• Personal history data
• Medical record
• Contact log for events and planning

Getting Started with Online Health

• Consent is assumed after creating settings
• Data is secured when the device functions properly

Technological Strategies of Healthcare

• Frameworks for digital security involve ethical responsibilities to consider
• A singular goal to use existing frameworks to help promote healthcare in France