Overview of legal and regulatory aspects Sample Clauses

Overview of legal and regulatory aspects. Table 3 provides an overview of the legislation and regulations that have been identified in relation to these legislative / regulatory fields at European and national governance levels. The table covers the following dimensions:  Data protection & data privacy.  Liability.  Licensing & quality control.  Patient Rights.  Ethics approval.  Sectoral / organisational codes of practice and guidelines. Table 3: Overview of legal and regulatory aspects of potential relevance to the service scenarios to be piloted Governance level Legislation / regulation of potential relevance Data protection & data privacy EU Directive 95/46/EC (Data Protection Directive) on the protection of individuals with regard to the processing of personal data and the free movement of such data. Directive 2002/58/EC concerning the processing of personal data and the protection of privacy in the electronic communications sector. Governance level Legislation / regulation of potential relevance Spain - Basque Country Organic law 15/1999 (13th December) on the Protection of Personal Data that guarantees and protects personal data, especially to preserve honour and personal and family privacy, as well as to exercise the personal right in case of alteration, loss, misuse or unauthorised access to data. This is applicable to any personal data in physical or electronic form. Decree 38/2012 (13th March) about the health record and the rights and obligations of patients and healthcare professionals with regards to the clinical documentation. This decree establishes a clear definition and update on the contents, use and access of the health record, as well as the rights and obligations of patients and professionals with regards to the clinical documentation registered in all clinical settings. This aims to create, for each patient, a unique health record, applying to public and private healthcare settings within the Basque Country. Agreement of Osakidetza´s Steering Committee (19th June 2006) that regulates personal files managed by Osakidetza. General Management Instruction 6/2003. Functions and obligations of Osakidetza's staff with respect to personal data protection. Action protocol. Royal Decree 994/1999. Safety of medical information 41/2002. UK - Wales UK Data Protection Act 1998. Data Protection (Processing of Sensitive Personal Data) Order 2000. Human Rights Act 1998. Access to Medical Reports Act 1988. Access to Health Records Act 1990. Freedom of Information Act 2000. Environmental...
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Overview of legal and regulatory aspects. Table 3 provides an overview of the legislation and regulations that have been identified in relation to these legislative / regulatory fields at the European and national governance levels. The table covers the following dimensions:  Data protection & data privacy.  Liability.  Licensing & quality control.  Patient Rights.  Ethics approval.  Sectoral / organisational codes of practice and guidelines. Table 3: Overview of legal and regulatory aspects of potential relevance to the service scenarios to be piloted Governance level Legislation / regulation of potential relevance Data protection & data privacy EU Directive 95/46/EC (Data Protection Directive) on the protection of individuals with regard to the processing of personal data and the free movement of such data. Directive 2002/58/EC concerning the processing of personal data and the protection of privacy in the electronic communications sector. UK - Northern Ireland UK Data Protection Act 1998 “Code of Practice on Protecting the Confidentiality of Service User Information” DHSSPS updated 2012 Records Management – Good Management Good records DHSSPSNI 2011 Freedom of Information Act 2000 Governance level Legislation / regulation of potential relevance Spain Personal Data Protection Law(1999) Organic Law 15/1999 of 13 December on the Protection of Personal Data (Orgánica de Protección de Datos 15/99) Safety of medical information 41/2002 Royal Decree 994/1999 Resolución de 15 de diciembre de 2009 del Secretario Autonómico xx Xxxxxxx sobre solicitud, tratamiento y cesión de datos de los sistemas de información de la Conselleria xx Xxxxxxx Valenciana Italy DL 196/2003 on privacy and data protection – see Annex Regional Council Decision n. 16 of 01.23.2014 Delibera 456 del 09/05/2014 del Direttore Generale ASL Xxxxxxx: Istituzione Comitato Etico Campania Sud - approvazione delibera n. 295 del 17/04/2014 del Direttore Generale ASL Napoli 3 Sud - individuazione componenti del Comitato Etico Campania Sud See also Appendix E and Annexes Portugal Personal Data Protection Article 35º from the Constitution of the Portuguese Republic – Use of Computers Law n.º 67/98. DR 247/98 SÉRIE I-A 1998-10-26 – Law of data protection Law 43/ 2004 – Law of organizations and functioning of National Commission to the data protection (CNPD Letter of Fundamental Rights of the European, Union Nice on 7 December 2000 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 Directive 2002/58/EC of th...
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Overview of legal and regulatory aspects. Table 2 provides an overview of individual pieces of legislation / regulation that have been identified in relation to these legislative/ regulatory fields at the European and national governance levels. Table 2: Overview of legal and regulatory aspects of potential relevance to the service scenarios to be piloted Legislative / regulatory dimension Governance level Legislation / regulation of potential relevance Data protection & data privacy EU   Directive 95/46/EC (Data Protection Directive): on the protection of individuals with the regard to the processing of personal data and the free movement of such data. Directive 2002/58/EC concerning the processing of personal data and the protection of privacy in the electronic communications sector. Denmark   Act No. 429 of 31st May 2000 relating to the processing of personal data (Persondataloven) with accompanying regulations. Act No. 913 of 13th July 2010 relating to personal health filing systems and the processing of personal health data, relating to patients’ rights, health personnel etc. (Sundhedsloven) with accompanying regulations. Spain   Personal Data Protection Law(1999) Organic Law 15/1999 of 13 December on the Protection of Personal Data (Organic law 15/99) Safety of medical information 41/2002 Royal Decree 994/1999 UK-Scotland  UK Data Protection Act 1998 Freedom of Information (Scotland) Act 2002 Italy   DL 196/2003 on privacy and data protection – see Annex FVG Regional resolution n.1148/2013 on the constitution of the unique new Regional Ethical Committee See also Appendix E and Annexes Legislative / regulatory dimension Governance level Legislation / regulation of potential relevance Sweden  (on CCU) Personal Data Act in Sweden: Personuppgiftslag (1998:204) Eksote- Finland   Act on the Protection of Privacy in Electronic Communications 516/2004 (Attached) Act of Status and Rights of Patients 1992/785 (Attached) Personal data act 22.4.1999/523 (Attached) Tallinn- Estonia  Personal data protection act 2003 Liability UK - Scotland  UK Data Protection Act 1998 Freedom of Information (Scotland) Act 2002  Community Care & Health (Scotland) Act 2003 EU  Directive 2000/31/EC (known as the e-commerce directive)  Directive 85/374/EEC Product Liability  COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices  Diagnostic in vitro devices (DIR 98/79) EC Denmark  Act No. 429 of 31st May 2000 relating to the processing of personal data (Persondataloven) with accompany...
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Related to Overview of legal and regulatory aspects

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