A AA A CUATRECASAS Health Law Newsletter I Portugal August 2018 Contents > National legislation > lnfarmed - > Case-Law \ \ '
A AA CUATRECASAS A I. National legislation Gender Identity Law 38/2018 - D.R.151/2018, Series I of2018-08-07 Establishes the right to self-determination of gender identity and of gender expression and the right to the protection of sexual features. Legionella Disease Law 52/2018 - D.R. 159/2018, Series I of2018·08-20 Establish the legal regime of Legionella disease prevention and control by defining procedures related to the use and maintenance of networks, systems and equipment's favourable to its dissemination. Proceeds to the Amendment to Decree-Law 118/2013, of August 20, which approved the Energetic Certification System, the Regulation for Energetic Performance of Residential Units and the Regulation for Energetic Performance of Commercial and Services Units. Fifth Human Organ Trafficking Resolution from the Republic's Assembly (Parliament) 236/2018 - D.R. 151/2018, Series I of2018-08-07 Approves the Council of Europe Convention against Trafficking in Human Organs that determines the obligation of Member States to adopt legislative measures to establish criminal offenses for the illicit extraction and traffic of human organ and measures to protect its victims. National Health System (NHS) Law 55/2018- D.R. 159/2018, Series I of2018-08-20 Determines the obligatory adoption of public tender, in all healthcare units of the NHS regardless of legal nature, for the recruitment of recent specialist physicians, which concluded the specific curriculum and have been recognized by any healthcare umt of the NHS as a specialist in their own field of specialty. Regional Decree-Law 16/2018/M - D.R. 127 /2018, Series I of 2018-08-20 Establish the legal regime of incentives, within a framework of physician deficit, of physicians' hiring, regardless of legal relationship established, by the Healthcare System of the Autonomous Region of Madeira, E. P. E. H, iltlilw N,., ·t 2
A AA CUATRECASAS A Ministerial Dispatch 7432/2018 - D. R.150/2018, Series II of2018-08·06 Determines the long-term strategy to convert the healthcare units of National Health System into smoke-free zones. Central Administration of the National Health System, l. P. Resolution 943/2018 - D.R.161/2018, Series II of 2018-08-22 Determines the extinction of the Business and Center of Invoice Inspection Unit; the extinction of Public Acquisitions and Contract Management Unit; creates the Contract Management and Control of Public Expenditure on Medicine and Medical Devices Unit. Clinical Academic Centers Decree-Law 61/2018- D.R.149/2018, Series I of2018-08-03 Establishes the legal regime of clinical academic centers, creating material conditions for the integrated development of healthcare activities, lecturing and clinical research. Portuguese Nursing Association Ordinance 515/2018- DR 151/2018, Series I of2018·08·07 Establishes the specific skills profile of specialist nurse of mental health nursing. Portuguese Pharmacist Association Ordinance 584/2018 - DR 168/2018, Series II of 2018-08-31 Establishes the regulation for Hospital Pharmacy Specialist practitioner title of the Portuguese Pharmacist Association. Ordinance 585/2018 - DR 168/2018, Series II of 2018-08-31 Establishes the regulation for Pharmaceutical Industry Specialist practitioner title of the Portuguese Pharmacist Association. Ordinance 865/2018 - DR 168/2018, Series II of 2018-08-31 Establishes the regulation for Ordinance Specialist practitioner title of the Portuguese Pharmacist Association. Ordinance 587 /2018 - DR 168/2018, Series II of 2018-08-31 Establishes the regulation for Laboratory Tests Specialist practitioner title of the Portuguese Pharmacist Association. H, iltlilw N,., ·t 3
A AA CUATRECASAS A Ordinance 588/2018 - DR 168/2018, Series II of 2018-08-31 Establishes the regulation for Human Genetics Specialist professional title of the Portuguese Pharmacist Association. II. lnfarmed, I. P. Information Note 111/CD/100.20.200 of2018-08-03 Clarifies the legal regime and obligation of previous report to lnfarmed, I. P. related to the administration of rapid screenings of HIV, HCVand HBV. Combined Ordinance 01/ACSS/INFARMED/SPMS of 2018-08-08 Establishes the obligatory legal and technical requisites, binding to all hospitals of the NHS, for the implementation of security devices on medicinal products. Ill. Case-law Health Data Protection Supreme Administrative Court Decision, Case 0394/18 of 2018-08-08 Decides that the access of healthcare information, deposited in the healthcare units, is accessible by third parties, in case the rightful owner of the data is incapable of providing informed consent (even though with full legal capacity) and always through the medium of a physician. The third party must demonstrate to fundamentally be entitled to a «direct, personal, legitimate and constitutionally protected right sufficiently relevant, under the consideration of all relevant fundamental rights at question and the principles of proportionality and of diligent and transparent administration, in order to access to the protected health data. In that case, the health data may be transmitted to the third party, but only the indispensable data relevant to the licit exercise of the fundamental right that justifies the third party access. H, iltlilw N,., ·t 4
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