The Right to Repair Software-Dependent Medical Devices

被引：2

作者：

Lindgren, Lars ^{[1
,2
,3
]}

Kesselheim, Aaron S. ^{[1
,2
,5
,6
]}

Kramer, Daniel B. ^{[4
]}

机构：

[1] Brigham & Womens Hosp, Dept Med, Program Regulat Therapeut & Law PORTAL, Div Pharmacoepidemiol & Pharmacoecon, Boston, MA USA

[2] Harvard Med Sch, Boston, MA USA

[3] Harvard Law Sch, Cambridge, MA USA

[4] Harvard Med Sch, Richard A & Susan F Smith Ctr Outcomes Res Cardiol, Beth Israel Deaconess Med Ctr, Boston, MA USA

[5] Harvard Med Sch, Ctr Bioeth, Boston, MA USA

[6] Harvard Med Sch, Brigham & Womens Hosp, Program Regulat Therapeut & Law, Boston, MA 02115 USA

来源：

JOURNAL OF LAW MEDICINE & ETHICS | 2022年 / 50卷 / 04期

关键词：

Medical Device Regulation; Health Policy; Medical Software; Digital Health;

D O I：

10.1017/jme.2023.28

中图分类号：

B82 [伦理学（道德学）];

学科分类号：

摘要：

The "right to repair" movement highlights opportunities to reduce health care costs and promote public health resilience through increased competition in the way in which medical devices are serviced and updated over their lifespan. We review legislative and legal facets of third-party repair of medical devices, and conclude with specific recommendations to help this market function more efficiently to the benefit of patients and health care systems.

引用

页码：857 / 859

页数：3

共 50 条

[21] Verification and Validation in the Recommended Practice for Integrated Software-Dependent Systems Assessing and improving processes in the Maritime and Oil & Gas industries
Coq, Thierry
2009 FIRST INTERNATIONAL CONFERENCE ON ADVANCES IN SYSTEM TESTING AND VALIDATION LIFECYCLE, 2009, : 57 - 61
[22] Uses of Software Interfaces in the Study of Commercial Medical Devices
Kozikowski, Raymond
Winslow, Andrew
Shang, Allan
ANESTHESIA AND ANALGESIA, 2007, 105 : S105 - S106
[23] Including off-the-shelf software in medical devices
Bartoo, G
IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE, 2003, 22 (06): : 104 - 105
[24] Challenges and opportunities in software-driven medical devices
Gordon, William J.
Stern, Ariel D.
NATURE BIOMEDICAL ENGINEERING, 2019, 3 (07) : 493 - 497
[25] Security vulnerabilities in healthcare: an analysis of medical devices and software
Mejia-Granda, Carlos M.
Fernandez-Aleman, Jose L.
Carrillo-de-Gea, Juan M.
Garcia-Berna, Jose A.
MEDICAL & BIOLOGICAL ENGINEERING & COMPUTING, 2024, 62 (01) : 257 - 273
[26] Software Reliability Allocation with Safety Concerns In Medical Devices
Chen, Qi
Wei, Yuan
Qin, Jin
2012 PROCEEDINGS - ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM (RAMS), 2012,
[27] Challenges and opportunities in software-driven medical devices
William J. Gordon
Ariel D. Stern
Nature Biomedical Engineering, 2019, 3 : 493 - 497
[28] DevOps in Regulated Software Development: Case Medical Devices
Laukkarinen, Teemu
Kuusinen, Kati
Mikkonen, Tommi
2017 IEEE/ACM 39TH INTERNATIONAL CONFERENCE ON SOFTWARE ENGINEERING: NEW IDEAS AND EMERGING TECHNOLOGIES RESULTS TRACK (ICSE-NIER), 2017, : 15 - 18
[29] Secure Method for Software Upgrades for Implantable Medical Devices
曹洋
胡春华
马伯志
郝红伟
李路明
王伟明
Tsinghua Science and Technology, 2010, 15 (05) : 517 - 525
[30] Security vulnerabilities in healthcare: an analysis of medical devices and software
Carlos M. Mejía-Granda
José L. Fernández-Alemán
Juan M. Carrillo-de-Gea
José A. García-Berná
Medical & Biological Engineering & Computing, 2024, 62 : 257 - 273

← 1 2 3 4 5 →