Reflection on the enactment and impact of safety laws for regenerative medicine in Japan.

Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framework intended to safely promote the clinical development of stem cell-based interventions (SCBIs) while subjecting commercialized unproven SCBIs to greater scrutiny and accountability. This article reviews ASRM's origins, explains its unprecedented scope, and assesses how it envisions the regulation of SCBIs. This analysis is used to highlight three key insights that are pertinent to the current revision of the ASRM: clarifying how the concept of safety should be defined and assessed in research and clinical care settings; revisiting risk criteria for review of SCBIs; and taking stronger measures to support the transition from unproven interventions to evidence-based therapies. Finally, the article reflects on lessons drawn from Japanese experiences in dealing with unproven SCBIs for international endeavors to regulate SCBIs.

Clínica médica especializada: norma técnica No. 18-2020-DRACES / Specialized medical clinic: technical standard No. 18-2020-DRACES

DRACES [Departamento de Regulación, Acreditación y Control de Establecimientos de Salud] Este documento tiene como objeto: "la regulación, autorización y control de las clínicas médicas especializadas, en concordancia con el Reglamento para la Regulación, Autorización, Acreditación y Control de Establecimientos de Atención para la Salud, Acuerdo Gubernativo 376-2007." Es de carácter obligatorio, por lo que se aplica en todo el territorio nacional. Contiene además, las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener cada clínica, incluidos el equipo y recurso humano y técnico.

[Radiation protection. Implications for clinical practice on the new regulations governing roentgen ray irradiation and radioprotection]. / Strahlenschuts. Auswirkungen der neuen Röntgenverordnung/Strahlenschutzverordnung in der Praxis.

In 2001 or 2002, the legislator made substantial alterations to the "Röntgenverordnung" [regulations governing use of roentgen ray radiation] and "Strahlenschutzverordnung" [regulations governing radiation protection]. This was done to bring German law in line with EU Directives 96/29/Euratom (basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation) and 97/43/Euratom (health protection of individuals against the dangers of ionizing radiation in relation to medical exposure). Proper use of radiation in medicine requires that those involved in its application are aware of the biological effect of radiation. When staff and others are protected good organization and appropriate technology at the workplace can achieve a great deal. In the new directives, the radiation protection for the patient is quantified and the responsibility of the physician is clearly pointed out. The most important aim is uniform quality throughout Europe in radiological diagnosis and radiation protection.

Your practice and infringement suits. Law affects patented medical procedures.

A 1996 law concerning patients on medical procedures is still causing change in health care. While the law was intended to exempt physicians from patent infringement during the practice of medicine, its final form contains ambiquities of medical group managers should remain aware.