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 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...
Sample 1
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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Related to Overview of legal and regulatory aspects

  • Legal and Regulatory Compliance The Consultant shall perform all services and prepare documents in compliance with the applicable requirements of laws, codes, rules, regulations, ordinances, and standards.

  • Legal and Regulatory Actions Contractor represents and warrants that it is not aware of and has received no notice of any court or governmental agency proceeding, investigation, or other action pending or threatened against Contractor or any of the individuals or entities included in numbered paragraph 1 of these Contract Affirmations within the five (5) calendar years immediately preceding execution of this Contract or the submission of any related Solicitation Response that would or could impair Contractor’s performance under this Contract, relate to the contracted or similar goods or services, or otherwise be relevant to System Agency’s consideration of entering into this Contract. If Contractor is unable to make the preceding representation and warranty, then Contractor instead represents and warrants that it has provided to System Agency a complete, detailed disclosure of any such court or governmental agency proceeding, investigation, or other action that would or could impair Contractor’s performance under this Contract, relate to the contracted or similar goods or services, or otherwise be relevant to System Agency’s consideration of entering into this Contract. In addition, Contractor acknowledges this is a continuing disclosure requirement. Contractor represents and warrants that Contractor shall notify System Agency in writing within five (5) business days of any changes to the representations or warranties in this clause and understands that failure to so timely update System Agency shall constitute breach of contract and may result in immediate contract termination.

  • Regulatory Affairs Development and production of medical products and processes fall under the purview of the Food and Drug Administration (FDA) and research on these products involving animal or human studies is regulated by other laws, directives, and regulations. Project Awards under this Agreement that involve work in support of or related to FDA regulatory approval will address contingencies for Government access to regulatory rights in the event of product development abandonment or failure. Efforts conducted under this OTA shall be done ethically and in accordance with all applicable laws, directives, and regulations. The Government shall ensure performance includes regulatory expertise and guidance for candidate medical countermeasure development efforts:

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Quality Assurance Requirements There are no special Quality Assurance requirements under this Agreement.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).

  • Responsibility of school staff to  design and implement engaging and flexible learning experiences for individuals and groups  inform parents and carers regularly about how their children are progressing  design and implement intellectually challenging learning experiences which develop language, literacy and numeracy  create and maintain safe and supportive learning environments  support personal development and participation in society  xxxxxx positive and productive relationships with families and the community  inform students, parents and carers about what the teachers aim to teach the students  teach effectively and set the highest standards in work and behaviour  clearly articulate the school’s expectations regarding the Responsible Behaviour Plan for Students and the school’s Dress Code policy  ensure that parents and carers are aware that the school does not have personal accident insurance cover for students  advise parents and carers of extra-curricular activities operating at the school in which their child may become involved (for example Program of Chaplaincy Services, sports programs)  set, xxxx and monitor homework regularly in keeping with the school’s homework policy  contact parents and carers as soon as is possible if the school is concerned about the child’s school work, behaviour, attendance or punctuality  deal with complaints in an open, fair and transparent manner in accordance with departmental procedure, Complaints Management – State Schools  treat students and parents with respect . I accept the rules and regulations of the Xxxxxx Road State School as stated in the school policies that have been provided to me as follows: □ Responsible Behaviour Plan for Students □ ICT Network Agreement □ Consent Form □ Parents Notice for Religious Instruction in School Hours Information provided in Parent Handbook: □ Complaints Management – Section 8.1 □ Student Dress Code – Section 10.0 □ Homework – Section 7.0 □ Voluntary Financial Contributions – Section 3.8 □ Absences – Section 12.1 □ School Excursions – Section 5.4 □ Accident Insurance Cover for Students – Section 3.9 □ Appropriate Use of Mobile Phones and other Electronic Equipment by Students – Section 8.5 I acknowledge:  That I have read and understood the responsibilities of the student, parents or carers and the school staff outlined above; and  That information about the school’s current rules, policies, programs and services, as outlined above has been provided and explained to me. Student Name: Student Signature: …….……………………… Parent/Carer Name: Parent/Carer Signature: ..……………………. Xxxxxxx Xxxx (Principal) / Xxxxxx Scammells & Xxxxx Xxxxxx (Deputy Principals): …….…………………………………

  • Statutory and Regulatory Compliance Contractor shall comply with all laws and regulations applicable to the Community Development Block Grant-Disaster Recovery funds appropriated by the Disaster Relief Appropriations Act, 2013 (Pub. L. 113-2), including but not limited to the applicable Office of Management and Budget Circulars, which may impact the administration of funds and/or set forth certain cost principles, including the allowability of certain expenses.

  • Fingerprinting Requirements Contractor hereby acknowledges that, if applicable, it is required to comply with the requirements of Education Code Section 45125.1 with respect to fingerprinting of employees who may have contact with the District's students. The Contractor shall also ensure that its Contractors on the Project also comply with the requirements of Section 45125.1. If required by Education Code Section 45125.1, the Contractor must provide for the completion of a Fingerprint Certification form, in the District’s required format, prior to any of the Contractor's employees, or those of any other Contractors, coming into contact with the District's students. Contractor further acknowledges that other fingerprinting requirements may apply, as set forth in Education Code Section 45125 et seq., and will comply with any such requirements.

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