scholarly journals The Medical Service Law and its Related Regulations : Steps to Be Taken for the Law by Medical Device Industries

2003 ◽  
Vol 59 (4) ◽  
pp. 484-485
Author(s):  
TOSHIO HAYAKAWA
2016 ◽  
pp. 69-74
Author(s):  
Vasyl Grigoriychuk

This survey article presents a review and analysis of the most pressing problematic issues of legal nature arising in the work of the department of forensic examination of corpses of medical examiner’s offices of Ukraine with reference to relevant legal documents, orders and regulations. In our opinion such topical issues causing debates are: contents of article 238 (part 4) of the Criminal Procedure Code of Ukraine, regarding the issue of when the corpse can be handed over for burying - only after performing (that is, completion) of forensic medical examination and establishment of the cause of death with drawing up the “Medical examiner’s conclusion”, or after the autopsy of the body, to whom exactly the corpse has to be handed over; to whom medical certificate of death has to be issued, taking into consideration provisions of item 2 of the “Regulations for filling out and issuance of medical death certificate”, who is to establish relatives of the deceased in compliance with the effective laws and how to understand the definition “a person who is undertaking to bury the deceased”; how to deal with the letters and inquiries pertaining to the disclosure of data obtained in the result of forensic medical examination sent to the bureau’s address by the “not judicial-investigative authorities”, presence or absence of legal documents, regulating actions of the medical examiner connected with the procedure of performance (or non-performance) of forensic medical examination of corpses of the nationals of foreign countries. At the same time conclusions have been made from this article pertaining to the vision of the ways for resolving the presented problematic issues in order to make easier, improve and optimize functioning of the department of forensic examination of corpses. The main legal document the most often referred to in the work of the department of forensic examination of corpses is the Code of Criminal Procedure of Ukraine (with amendments made in accordance with the Law #5076-VI of 05.07.2012) that brought in new requirements and innovations in the work of forensic medical service of Ukraine. It should be noted, that in this legal document we have found 19 articles that deal directly or indirectly with the work of doctors medical examiners. Aside from this document we must also take into consideration the following effective legislative acts: “Regulations for filling out and issuance of medical death certificate (Form #106/o)”, approved on the order of the Ministry of Public Health of Ukraine #545 of 08.08.2006; “The procedure of carrying out investigation and registration of casualties, occupational diseases and industrial accidents”, approved by the Decree of the Cabinet of Ministers of Ukraine #1232 of 30.11.2011; the Law of Ukraine “On advocacy and legal practice”, the Law of Ukraine “On burial and undertakers’ business”. Conclusions: to improve the quality of work of the department of forensic medical examination of corpses in particular and forensic medical service in general, to avoid and bring down to the minimum the problems of legal nature arising in practical work of doctors-medical examiners it is necessary, in our opinion, to resolve the following problematic issues: To provide explanation of contents of article 238 (part 4) of the Code of Criminal Procedure of Ukraine in the part stating, that “the corpse can be handed over … only after performing forensic medical examination and establishing the cause of death”. Solicit competent authorities to make additions or amendments to article 238 of the Code of Criminal Procedure of Ukraine binding indication of the name of person to whom the corpse can be handed over from the morgue for To resolve the problem of responding to the inquiries from various enterprises, establishments and organizations requesting to provide results of the performed forensic medical examination of corpses, copies of the conclusions of expert examination taking into consideration provisions of article 69 (part 5) and article 222 (parts 1, 2) of the Code of Criminal Procedure of Ukraine. Resolve the problem of legal aspects of performing forensic medical examination of corpses of foreign


1987 ◽  
Vol 110 ◽  
Author(s):  
John L. Ely

AbstractPremarket review processes as prescribed by the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act greatly affect the use of materials in medical products, especially for implantable devices. The premarket approval process can have a particularly important role in eventual commercial medical uses of materials. Managing the process properly is often critical to the success or failure of a product.A review of the law and regulations as they pertain to premarket approval is presented. Subjects included in this overview are prediction of process time and costs, examination of potential pitfalls in the process, recommendations on organizing for successful completion of the process and handling the relationship with FDA.Specific materials related issues that are likely to arise are noted.


SOEPRA ◽  
2020 ◽  
Vol 6 (2) ◽  
pp. 1
Author(s):  
Irma HY Siregar

ABSTRACTThere are thirteen kinds of health workers in Health Facility, and one of them is Dental Therapist which categorized as medical technician. The Law Number 39/2014 has changed the allocation of Dental Therapist from nursing group to medical technician group. But, their authority is the same with Dental Nurse. In the Minister of Health regulation Number 20/2016 about Licence and Practice of Dental Therapist, there is an authority to give limited medical service to the patient. The research’s approach was normative juridic by evaluating the laws with applicable laws and regulations. The result was there were three sources of Dental Therapist’s authorities which were Attribution, Delegation, and Mandate. These authorities should carry out in Health Facility and not in Independent PracticeKeyword: Dental Therapist, Authority, Medical Service ABSTRAKTenaga kesehatan yang memberikan pelayanan di Fasilitas Kesehatan saat ini dikategorikan dalam 13 jenis dan salah satunya adalan tenaga Terapis Gigi dan Mulut yang termasuk dalam rumpun Keteknisian Medis. Undang Undang Nomor 39 Tahun 2014 telah mengubah mengubah penempatan Terapis Gigi Mulut (dulu bernama Perawat Gigi) dari rumpun keperawatan menjadi rumpun keteknisian medis. Dalam hal ini terlihat bahwa kewenangan seorang terapis gigi dan mulut tidak berbeda seperti halnya kewenangan perawat gigi walaupun bukan lagi dapat dikategorikan sebagai seorang perawat. Dalam Peraturan Menteri Kesehatan Nomor 20 Tahun 2016 tentang Izin dan Penyelenggaraan Praktik Terapis Gigi dan Mulut terdapat kewenangan dalam pemberian pelayanan tindakan medik terbatas kepada pasien. Pendekatan penelitian ini dengan menggunakan pendekatan yuridis normatif dengan melakukan kajian hukum melalui berbagai sistem peraturan perundang-undangan yang ada. Hasil dari penelitian ini menunjukkan ada 3 sumber kewenangan yang dimiliki terapis gigi dan mulut yaitu kewenangan atribusi, kewenangan delegasi dan kewenangan mandat yang dapat dilakukan di Fasilitas Pelayanan Kesehatan dan bukan di Fasilitas Praktik Mandiri. Kata Kunci: Terapis Gigi dan Mulut, Kewenangan, Pelayanan Medik


2016 ◽  
Author(s):  
Annemarie Bridy

The law of trade secrets has taken a back seat to copyrights and patents in the explosion of scholarship on intellectual property issues over the last decade. While scholars concerned for the future of the public domain have argued forcefully and persuasively against the continuing expansion of rights - both in scope and duration - for holders of copyrights and patents, they have said little about the corresponding "creep" that has been occurring in the law of trade secrets. This article examines some of the causes and effects of that "creep" in the context of recent claims by the medical device manufacturer Guidant that the actual prices its hospital customers pay for implantable devices, including cardiac pacemakers and defibrillators, are protectable as trade secrets under the Uniform Trade Secrets Act ("UTSA").Annemarie BridyProfessor<http://www.uidaho.edu/law/faculty/annemariebridy>|University of Idaho College of Law|PO Box 83720-0051|Boise, ID 83720|Ph. 208.364.4583Affiliate Scholar<https://cyberlaw.stanford.edu/about/people/annemarie-bridy>|Stanford Center for Internet and SocietyAffiliate Fellow<http://isp.yale.edu/people-directory?type=19>|Yale Information Society ProjectSSRN<http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=630766>|HeinOnline<http://heinonline.org/HOL/AuthorProfile?collection=journals&search_name=Bridy,%20Annemarie&base=js>|LinkedIn<https://www.linkedin.com/in/annemariebridy>|Twitter<https://twitter.com/AnnemarieBridy>


2019 ◽  
Vol 18 (1) ◽  
pp. 8-10
Author(s):  
G. S Petrov ◽  
I. L Krom ◽  
M. V Erugina

The article is devoted to autonomy of patient as applied to postmortem donors of organs. The conclusion is made on the basis sociological approach and analysis of legal concepts of «medical service», «medical intervention» and «patient» as related to postmortem organ donorship, about priority of assessment of this particular issue. The attempts of applying regulations of the law on funeral business to postmortem organ donors is inadmissible. The suggestion is developed to consider consent presumption of posthumous organ donorship as a form of transition from autonomy of particular patient to autonomy of society given population support.


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