Clinical Records and Law

Code:

OPT164

Acronym:

DRC

Keywords
Classification	Keyword
OFICIAL	Medicine

Instance: 2019/2020 - 1S (of 09-09-2019 to 09-02-2020)

Active?	Yes
Responsible unit:	Department of Community Medicine, Information and Health Decision Sciences
Course/CS Responsible:	Integrated Master in Medicine

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MIMED	23	Mestrado Integrado em Medicina- Plano oficial 2013 (Reforma Curricular)	2	-	3	28	81
			3

Teaching language

Portuguese and english

Objectives

1. Acquisition of basic knowledge in the specific field of clinical records and the rights and duties inherent thereto;


2. Understanding of the same knowledge;


3. Application of acquired knowledge;


4. Analysis of this knowledge;


5. A summary of the knowledge acquired, with particular reference to the issues of access, re-use, security of clinical records and data protection of natural persons, as well as the impact of these basic and elementary notions on their practices, even as students of medicine, in the future already as doctors and in the rights of all, sick included;


6. Assessment of knowledge acquisition, understanding and application, analysis and synthesis of knowledge.

Learning outcomes and competences

-

Working method

Presencial

Program

1. Previous concepts

1.1. The coercive power of the legal norm, as a distinctive element between law and ethics

1.2. Concept of legal good vs. protection and protection of the right

1.3. Legal goods related to clinical records

1.3.1. The Right to Privacy and Confidentiality

1.3.2. The duty of secrecy and medical secrecy

1.4. De jure constituendo, the secret of the medical student.

1.5. The safety, integrity, non-manipulation, preservation, preservation, and reliability of clinical records

1.6. The duty to provide information

1.7. The right of access to information

1.8. The right of re-use

1.8. The legal meaning of the clinical register, as a representation of a past reality

1.9. Essential legal aspects in a clinical register

 

1. The specific nature of clinical records

 

1. Legal consequences of its infringement

 

1. The multiplicity of interests and stakeholders in clinical records

4.1. Your immediate interest, care

4.2. Its usefulness in the investigation and exercise of teaching functions

4.3. Your interest in Administration of Justice

4.3.1. In the preparation of medical-legal

4.3.2. In the preparation of Technical-Scientific Opinions by the Medical-Legal Council

4.3.3. Syntagmatic and reciprocal interest

4.4. Its meaning and probative value

4.4.1. In the judicial field

4.4.2. In the field of institutional financing

4.5. As memory of institutions and representation in the evolution of knowledge

 

1. The Knowledge Society, the Right to Investigate and Access to Information: The Reuse of Clinical Records

5.1. Concept, meaning, meaning, objectives and scope of reuse

5.2. Legal framework for re-use for R & D purposes

5.3. The right to reuse as a researcher right

5.4. The authorization of holders of clinical records and their anonymization

5.5. The status of the investigator as guarantor of the rights of holders of clinical records

5.6. DAtaREuseCertificate for Research (DARE) certification of the Suitability of sources and the legality of access.

5.6.1. Transparency and reproducibility of research

5.6.2. Security of investigators, guardians and publishers

 

1. The Clinical Records in the Portuguese legal system

6.1. Legal concept of health information

6.2. The duty to draw up clinical records

6.3. Ownership of the clinical process

6.4. Meaning and significance of keeping a clinical record

6.5. Access to clinical records

6.6. The legal certainty of clinical records

 

1. Legal consequences of the absence of clinical records and their origin for imputation of responsibilities

7.1. The legal responsibility of the physician

7.2. The legal responsibility of health facilities

7.2.1. Ensure the preservation of the nature of permanent conservation

7.2.2. Ensure access

7.2.3. Ensuring safety

7.2.4. Ensure the guard

7.2.5. Ensure integrity

 

1. The national legal order and the directives of the European Parliament and of the Council

8.1. In access to clinical records

8.2. In the safety of clinical records

8.3. In re-use of clinical records for R & D purposes

8.4. In re-use of clinical records for educational purposes

8.5. In the protection of natural persons

 

1. Different levels of legal responsibility, v. clinical records

9.1. Disciplinary responsibility

9.2. Civil liability

9.3. Criminal responsibility

9.4. The principle of Open Administration, meaning, meaning and limits in relation to clinical records

9.4.1. Meaning, meaning and limits

9.4.2. The conflict of rights between duty to inform and medical confidentiality

 

1. The Right to Audit a Clinical Record

10.1. The legal classification of permanent preservation of clinical records

10.2. Legal liability for custody

 

1. Legal concerns in the design of software that supports health information

11.1. Identity of who acceded

11.2. To what end (report of grounds)

11.3. When and where (date and equipment)

11.4. What level of authorization did you have vs What level did you use?

11.5. You tried to use the level for which you had no authorization

11.6. The concrete situation legitimized "Break the Glass"

11.7. Internal Audits and Reporting

11.8. External audits by independent entities

 

1. Security in access and the need for self-assessment tools and internal and external control

12.1. Building Alerts

12.2. Mandatory and automatic notifications

12.3. Preservation and non-manipulation guarantees

12.4. Internal Audits and Reporting

12.4.1. By clinical process, with identification of the natural person and reason

12.4.2. By natural person, with identification of the process and reason

12.5. External audits by independent entities | Universities

 

1. The Commission for Access to Administrative Documents (CADA) and the intervention of RAI (Responsible for Access to Information)

13.1. What is CADA and what are its competences

13.2. Legal value of CADA's deliberations

13.3. RAI as a legal figure in access to information

13.4. The role of RAI in the specific field of access to health information

13.5. Origins of requests to RAI

13.6. Law, Doctrine and Jurisprudence that underpins RAI's decisions

 

1. The National Commission for Data Protection (CNPD) and the intervention of the RTD (Data Processing Officer)

14.1. What is the CNPD and what are its competences

14.2. Legal value of CNPD's deliberations

14.3. The role of the CNPD in the specific domain of access to health information

14.4. The safety and protection of health information

 

1. The Regulation of the European Parliament and of the Council on the protection of individuals (RGPD)

15.1. Subject matter, Objectives, Territorial and material scope

15.2. Definitions

15.3. Principles concerning the processing of personal data

15.4. Responsible for Treatment and Subcontractor

15.5. Subcontractor

15.6. Security of Personal Data

15.7. Data Protection Officer, designation, position and duties

15.8. Codes of Conduct and Certification

15.9. Transfer of Personal Data to Third Countries or International Organizations

15.10. Binding rules applied to enterprises

15.11. International cooperation in the field of personal data protection

15.12. Independent Control Authorities

15.13. European Data Protection Committee

15.14. Appeals, Liability and Sanctions

15.15. Specific Treatment Situations

 

 

1. The dispersion of positive law, de jure constituto, and the need to rethink it, de jure constituendo

16.1. Essential and imperative elements of a clinical record

16.2. The initial end in which they take place

16.2.1. The provision of health care

16.2.2. The administration of justice

16.3. Its design

16.4. Different plans of interest, immediate and medium

16.5. Management

16.6. Preservation and non-manipulation

16.7. Access

16.8. Reuse

16.8.1. For research and development (R & D)

16.8.2. For educational purposes

16.9. Exchange

16.10. Non-communicable information

16.10.1. Third Party Registrations

16.10.2. Personal notes

16.11. Property

16.11.1. Legal, attributed to the holder

16.11.2. Intellectual

16.12. The legal and institutional ownership and responsibility of the

16.13. Audit

16.13.1. By health professionals, intellectual authors of clinical records

16.13.2. A wrong access

16.13.3. The security

16.14. Different security plans

16.14.1. Legal

16.14.2. Physics, logistics and software algorithms that support and represent clinical records and the networks where they circulate

16.14.3. In technical assistance to software and networks

16.15. Scope:

A single and exclusive legal instrument regulating all the dynamics and purposes inherent in clinical records and their impact on the protection of the personality rights of natural persons, whether these natural persons are the patients or health professionals who are the intellectual authors of those registers, whether individuals public law, universities, research centers, hospitals, or private law.

Mandatory literature

-; DIRECTIVA 2003/98/CE DO PARLAMENTO EUROPEU E DO CONSELHO de 17 de novembro de 2003 relativa à reutilização de informações do sector público
-; DIRETIVA 2013/37/UE DO PARLAMENTO EUROPEU E DO CONSELHO, de 26 de junho de 2013 que altera a Diretiva 2003/98/CE relativa à reutilização de informações do setor público
-; DIRETIVA (UE) 2016/680 DO PARLAMENTO EUROPEU E DO CONSELHO de 27 de abril de 2016 relativa à proteção das pessoas singulares no que diz respeito ao tratamento de dados pessoais pelas autoridades competentes para efeitos de prevenção, investigação, deteção o
-; Lei 12/2005, de 26 de janeiro, sobre Informação genética pessoal e informação de saúde
-; Lei 46/2007, de 24 de agosto, que Regula o acesso aos documentos administrativos e a sua reutilização, revoga a Lei n.º 65/93, de 26 de agosto, com a redacção introduzida pelas Lei n. 8/95, de 29 de março, e 94/99, de 16 de julho, e transpõe para a ordem ju
-; Lei 26/2016, de 22 de agosto, que aprova o regime de acesso à informação administrativa e ambiental e de reutilização dos documentos administrativos, transpondo as Diretivas 2003/4/CE, do Parlamento Europeu e do Conselho, de 28 de janeiro, e a Diretiva 2003

Teaching methods and learning activities

Theoretical-practical classes (TP) classes with great interactivity with students through a methodology of systematic questions on the topics to be addressed. The process of evaluation is continuous, according to a systematized order of knowledge, understanding, application, critical analysis and synthesis, culminating with the evaluation. The theoretical approach is made with systematic questions addressed to the students, in such a way that the participation of all is guaranteed, which simultaneously allows to assess the level of knowledge, the understanding of the same, the ability to apply them and on them critical analysis and synthesis.

Practical questions are placed weekly on the topics covered, with the quotation of each question, which allows a continuous and practical assessment and guarantees transparency and fairness in the students' evaluation. The results of the weekly evaluation are published weekly. The sum of these weekly assessments will be weighted at 60%. In the last class, there is a written exam, with ten questions of Boolean answer, with a quotation of one value each, and a topic for development with the quotation of ten values. The weighting of this final exam is 40% and it is not allowed to consult legal diplomas or supporting texts.

Evaluation Type

Distributed evaluation with final exam

Assessment Components

Designation	Weight (%)
Exame	40,00
Trabalho escrito	60,00
Total:	100,00

Amount of time allocated to each course unit

Designation	Time (hours)
Estudo autónomo	38,00
Frequência das aulas	28,00
Trabalho escrito	15,00
Total:	81,00

Eligibility for exams

To obtain frequency, the students must be present in 75% of the classes

Calculation formula of final grade

Weekly assignments - 60%
Final exam - 40%