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Watch the video

Dr. Ommen illustrates the projects of the  "Connective Care Centre” of the Mayo Clinic as its own Director 

Slide
e-health quadro generale

Silvia Stefanelli's slide presentation about "EU legislation framework on e-Health"

Click here to download the slides

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The ECHAlliance and Stefanelli & Stefanelli work together at a strategic level to promote connected health initiatives

E – HEALTH: DR. STEVE OMMEN DESCRIBES THE SERVICES PROVIDED BY THE CONNECTIVE CARE CENTRE OF MAYO CLINIC (ROCHESTER – MINNESOTA)

12 lug 2016

In the wake of the conference "ITALY – US Meeting, a new research model for the development of digital health", organized in December 2015 by our Firm, by “CIRSFID” from Bologna University and by the legal-scientific journal E-sanita@, we have the great pleasure to make available on our website the video recently released by Dr. Steve Ommen, who attended the conference as one of its prestigious speakers, about the services provided by the "Connective Care Centre” of the Mayo Clinic as its own Director. [...]

HEALTH CARE- new technologies-

NBC paper explores bioethics concerns posed by mHealth

Silvia Stefanelli-
23 set 2015

On 28 May, the Italian NationalBioethics Committee (‘NBC’) published a paper entitled ‘MobileHealth Apps: bio-ethical aspects.’ The paper presents a survey ofseveral bioethics problems involving mobile health (‘mHealth’) and identifies possible solutions.

Published on eHealth Law and Policy - July 2015

The publisher has kindly authorized Stefanelli & Stefanelli Law Firm to post it on our web site

HEALTH CARE- new technologies-

The Garante issues guidelines for processing health file data

23 set 2015

Recently, Italian regulators have undertaken initiatives to administer efficient and effective healthcare by developing electronic networks and expanding the computerised management of records, documents, and  processes. To contribute to this, the Italian Data Protection Authority (‘DPA’), the Garante, published a new set of guidelines in Italy’s Official Gazette on 17 July on electronic patient records, aimed at providing greater protection for patient data. Silvia Stefanelli of Stefanelli & Stefanelli Law Firm and Amandeep Gargi, Strategy Consultant at the Chinese Dental Cooperation, an Italian start-up, provide detailed analysis of the new guidelines.

Published on: eHealth Law and Policy - August 2015

The publisher has kindly authorized Stefanelli & Stefanelli Law Firm to post it on our web site

HEALTH CARE- new technologies-

NEW STEP FOR MEDICAL DEVICES REGULATION

Silvia Stefanelli-
26 giu 2015

On 19 June 2015, the Council agreed the substance of its negotiating stance on two draft regulations aimed at modernising EU rules on medical devices and in vitro diagnostic medical devices.

Full Article [...]

Abstract

2015年6月19日欧盟理事会通过了关于两个项目的协议,欧盟的规则现代化:-医生和设施医学诊断。

理事会同意欧盟轮值主席与欧洲各国议会进行谈判协商对医疗器械新规则总结如下...

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Medical Device Advertising in Italy: new prospective

Silvia Stefanelli-
05 feb 2015

Abstract

The Italian legislation on Medical Devices includes very restrictive rules about medical Device advertising (not included in ECC Directive).

Although advertising authorisation is still mandatory, the MOH’s actual approach about medical advertising authorisation is more “flexible” than in the past due to a new case law.

In the last two years, the new liberalization “wind” influenced the court decisions: here's the most relevant news.

在意大利医疗器械广告新前景展望:

意大利对医疗器械的立法包括医疗器械的广告(不包括在欧盟指令)有非常严格的规定。法令的第21条第46/97号对医疗器械广告设置有两种不同的类别:1)严禁医疗器械的广告; 2)没有卫生部的批准禁止广告。但随着2006/02/23发布的涉及到上述规则范围主题的部长令,法律开始更灵活的应用在这个领域。卫生部最近决定,以评估对医疗器械广告应​​用程序,应用有效的关于保健品广告的新规则。这些标准已经在2011/83中第90条列出。

虽然授权的广告仍然是强制性的,但卫生部批准的医疗广告目前的做法是因为新的法律比过去更加“灵活”。意大利政府已经颁布了法律2012/27(第90号。F.),以开放意大利市场。关于医疗器械的广告宣传中最重要的决定,2014/n.8943已经在拉齐奥大区发出,上述新的原则得到应用。

Fulla Article [...]

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e-Health legislation development in Italy and EU

Silvia Stefanelli-
22 dic 2014

On December the 19th, the Minister of Health presented a Report on the Healthcare situation in Italy related to the years 2013-2014

This report is the most important document in the italian institutional communication about public health: through it the Minister of Health provides information on the health situation and the implementation of health policies.

In this document you can find a sector on the e-health legislation development in Italy and EU.

Click here to see the flowchart that summarizes this development.

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Telemedicine service in China

Silvia Stefanelli-
21 dic 2014

On 25 October 2014, Guangdong No. 2 Provincial People’s Hospital launched telemedicine to patients.This is the first hospital to provide telemedicine in China.This article written by our colleague Cai Jin summerizes the most revelant aspects of this project.  

广东医院率先在中国(201410月)享有远程医疗的权力

定义:远程医疗是一种医疗机构由电信(计算机,网络技术)技术支持,并通常由医疗机构通过网络处理病人情况,以达到恢复健康的行为手段。

目的:促进病人与医院的联系,因此随时协商病人易于接受的治疗。

方式:通过协商,医疗机构为病人通过本地网络配置视频,满足病人需求。

法律问题:

1法律禁止上线医药规定项目。因此,网上销售药物要符合这些管理措施(2014年5月28日)。

2 法律和实践的矛盾:管理措施中的药方,要求由医院或者广东的医生签字,但实际上这项措施没有这样做。

3 缺乏统一的国家政策策略。该系统是省级人民政府的当地系统,病人不能利用远程医疗在另一个省进行治疗。

4 从国家规定的已批准使用的药品,缺乏用在不同目的,即出现了非法行医的风险。

5 医生对患者进行视频访问,涉及病人的隐私问题。

6 矛盾冲突:2014年8月授权的远程医疗可以与国外医疗机构合作(依据2000 年7月1日的法规),现在它需要事先在当局得到批准。

 

→需要一个更全面的立法框架:广东的做法是不够全面的,电子商务的需求(在手机上的保健服务,网上销售药品)都没有听说过。

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mHealth: big challenge, big problems - the Apps qualification

Silvia Stefanelli-
28 ott 2014

Abstract

On Semptember, 9 Apple has launched HealthKit. The new creative idea of Cupertino company is bringing together practitioners, patients and people everywhere to make health efficient, effective and accessible all over the world.

移动电子保健:该应用程序的法律性质

欧盟委员会于2014年4月已经在文件/绿卡健康与手机/移动电子保健的框架内展开公众谘询,在打开欧盟手机应用潜力之前以确定正确的方式。

计算机语言1:应用服务的法律描述,应用在医疗领域所属的医疗装置的类别。一系列的答案文件如下:

1- 欧盟委员会在2012年1月:“MEDDEV2.1/6(医疗器械警戒系统)线路

和指导的应用于保健医疗器械的监管范围内的独立软件资格和分类。“

“医疗设备必须是合格的医疗设备。”例如:一个控制装置或者给予专业的医疗援助。

“关于分界线和医疗器械的欧盟监管框架的分类手册”,在我以前的文章有介绍以及标准清单,以确定是医疗设备的应用程序。

2- 指南上的独立软件医疗器械(包括应用程序),该机构的监管医疗产品和医疗英文,2014年3月。

应用程序的类别:计算软件帮助你做出决定,附件的应用程序:测量温度、压力等等。

3- 美国食品和药品局:指导医疗应用,2013年9月。

它定义了两类:应用程序的附件,以及卫生系统医疗设备转向手机应用,例如通过使用传感器的应用程序。

计算机语言2:欧盟法规2012/207对使用的医疗器械电子指令的应用。

Full Article [...]

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MEDICAL APPS: MORE TRANSPARENCY IS NEEDED ON DATA USE Half of the apps do not provide the users with the appropriate information before the download or request excessive datas

Silvia Stefanelli-
24 ott 2014

Abstract

On May 2014 the Italian PDA has launched a survey to check the compliance of the medical apps with the Italian legislation.

2014年9月,关于符合医学应用的资料数据库保护,意大利法律已经颁布.主要问题是:医学应用在安装前不会给出关于个人资料数据,或者这些资料很一般,或者限制太多。关于1200种应用只有15%给出关于个人的有用信息,担保者应当考虑有采取措施的可能性。

Full Article [...]

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Can a Italian company, producing its goods in China, partecipate as a tenderer in a procedure for the award of a public contract in Italy?

Silvia Stefanelli-
23 ott 2014

Abstract

The recent Court of Naples n. 4965 of 9 Semptembre 2014 answered to this question in a negative way.

有关问题:Napoli法院(2014年9月9日宣告书第4965号)已特别列出指明,一个在中国的意大利生产企业在意不可以共同使用授予的合同。原因:欧洲法令2004/17/EC和2004/18/EC不允许新兴的发展中国家参与这些过程,尽管中国从2001年已经加入世贸组织,不过中国政府的采购市场还不完善,没有充足的保障。

Full Article [...]

public contracts-

FDA issues two Draft Guidances for Industry on Social Media and Internet Communications

Silvia Stefanelli-
08 set 2014

Abstract

The FDA has just issued two draft guidances for industry with recommendations to help manufacturersand their representatives to accurately communicate online about prescriptiondrugs and medical devices

依据“食品和药物管理局(美国)”指定的医疗设备公司,当有独立的第三方传播错误信息,其有责任对第三方的误传做出回应,以帮助其产品。
第一个项目方案包含了推荐的药物和医疗器械信息的建议。
第二个项目方案建议来自于对第三方的误导有关他们的产品做出回应的公司

Full Article    [...]

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Updated EU Manual on Borderline: new instructions for app classification

Silvia Stefanelli-
08 set 2014

Abstract

The EU has just updated the ‘Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices’.

对医疗器械的监管框架和分类的手册有一章节是关于应用程序和软件作为医疗器械的资格标准。
这些标准不具有约束力(国际法院C-109/12)
- 处理心电图(诊断和治疗)的应用被认为是一个医疗设备
- 包含病人对医生的数据的应用程序是否是一个医疗设备
- 说明人体的应用程序是否是一个医疗设备.

Full Article [...]

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MEDICAL DEVICES: when medical device "repackaging" complies with legal rules

Silvia Stefanelli-
08 set 2014

Abstract

 The Court Of Milan (Italy) has just issued an interesting judgement regarding the "repackaging" of some medical devices which were subjected to parallel importation.

商标的保护米兰法院第二千零一十四分之三万零十四号法令(专业法庭)防止自由兑换的保护PB:在欧盟内部的品牌自由贸易保护
事实:一家意大利跨国制药公司对从其它欧洲国家市场进口的产品重新包装
依据:欧盟法院(C-379/97厄普约翰和C-348/04柏林格尔)两项决定,对于一般情况下不允许分装,除非可以证明分装的必要性

Full Article [...]

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