Hasil untuk "Medical legislation"

M. Aboy, Timo Minssen, E. Vayena

The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements? And, what are the obligations of ‘providers’ of these AI systems? After addressing these foundational questions, we discuss the AI Act’s broader implications for the future of regulated digital medical products.

A. Nambiar, Shivani Patel, Patricia Santiago-Munoz et al.

Nambiar. Maternal morbidity and fetal outcomes at 22 weeks’ gestation or less with complications in 2 Texas hospitals after legislation on abortion. Am J Obstet Gynecol 2022. (continued) OBJECTIVE: Recent state-level legislation on abortion has encroached on access to reproductive care with disproportionate effects on underserved communities. In Texas, 2 legislative actions have been at the forefront of this public health issue. Senate Bill 8 bans abortions once cardiac activity is identified using standard medical practice on the basis of the estimated gestational age with enforcement by private plaintiffs through civil lawsuits. Senate Bill 4 states that a physician administering medicine to end a pregnancy even in the setting of a maternal medical emergency has committed a felony, with jail time ranging from 180 days to 2 years and a $10,000 fine; it also expands abortion complication reporting. The current national standard of care of women not in labor presenting with rupture of membranes before neonatal viability allows expectant management or immediate delivery following shared decision-making. We report the experiences from 2 urban, inner-city healthcare systems in Texas after these legislative actions.

Landon D. Hughes, K. Kidd, K. Gamarel et al.

PURPOSE The standards of care for transgender and gender diverse youth (TGDY) experiencing gender dysphoria are well-established and include gender-affirming medical interventions. As of July 2021, 22 states have introduced or passed legislation that bans the provision of gender-affirming medical care to anyone under the age of 18 even with parent or guardian consent. The purpose of this study is to understand what providers who deliver gender-affirming medical care to TGDY think about this legislation. METHODS In March 2021, we recruited participants via listservs known to be frequented by providers of gender-affirming medical care. Eligible participants were over the age of 18, currently working as a physician, nurse practitioner, or physician's assistant, and providing gender-affirming care to TGDY under the age of 18 in the U.S. RESULTS We analyzed the responses of 103 providers from all 50 states and DC. Most participants identified as white (77%), cisgender women (70%), specializing in pediatric care (52%). The most salient theme, described by nearly all participants, was the fear that legislation banning gender-affirming care would lead to worsening mental health including increased risk for suicides among TGDY. Other themes included the politicization of medical care, legislation that defies the current standards of care for TGDY, worsening discrimination toward TGDY, and adverse effects on the providers. CONCLUSIONS Providers of gender-affirming care overwhelmingly opposed legislation that bans gender-affirming care for TGDY citing the severe consequences to the health and well-being of TGDY along with the need to practice evidence-based medicine without fear.

B. Dariš, Mojca Tancer Verboten, Ž. Knez et al.

The plant Cannabis sativa L. has been used as an herbal remedy for centuries and is the most important source of phytocannabinoids. The endocannabinoid system (ECS) consists of receptors, endogenous ligands (endocannabinoids) and metabolizing enzymes, and plays an important role in different physiological and pathological processes. Phytocannabinoids and synthetic cannabinoids can interact with the components of ECS or other cellular pathways and thus affect the development/progression of diseases, including cancer. In cancer patients, cannabinoids have primarily been used as a part of palliative care to alleviate pain, relieve nausea and stimulate appetite. In addition, numerous cell culture and animal studies showed antitumor effects of cannabinoids in various cancer types. Here we reviewed the literature on anticancer effects of plant-derived and synthetic cannabinoids, to better understand their mechanisms of action and role in cancer treatment. We also reviewed the current legislative updates on the use of cannabinoids for medical and therapeutic purposes, primarily in the EU countries. In vitro and in vivo cancer models show that cannabinoids can effectively modulate tumor growth, however, the antitumor effects appear to be largely dependent on cancer type and drug dose/concentration. Understanding how cannabinoids are able to regulate essential cellular processes involved in tumorigenesis, such as progression through the cell cycle, cell proliferation and cell death, as well as the interactions between cannabinoids and the immune system, are crucial for improving existing and developing new therapeutic approaches for cancer patients. The national legislation of the EU Member States defines the legal boundaries of permissible use of cannabinoids for medical and therapeutic purposes, however, these legislative guidelines may not be aligned with the current scientific knowledge.

Luis Jiro Suzuri Hernández, Alexa Villavicencio Queijeiro, Valeria Alexandra Alonzo Matamoros

En virtud de la importancia que, para la comunidad forense, tiene la perspectiva de las ciencias forenses planteada en el artículo publicado por Roux y Col. 2022, la Editora de la RCFH, considero importante traducir al español este trabajo y ponerlo a disposición de nuestros lectores. Este artículo es la traducción al español del documento original en inglés, titulado: “The Sydney Declaration – Revisiting the essence of forensic science through its fundamental principles”, escrito por Claude Roux, Rebecca Bucht, Frank Crispino, Peter De Forest, Chris Lennard, Pierre Margot, Michelle D. Miranda, Niamh NicDaeid, Olivier Ribaux, Alastair Ross y Sheila Willis, y publicado en la revista Forensic Science International, volumen 332, año 2022, cuyo original está disponible en: https://doi.org/10.1016/j.forsciint.2022.111182 La traducción fue realizada en marzo del 2024 por Luis Jiro Suzuri Hernández y Alexa Villavicencio Queijeiro, de la Escuela Nacional de Ciencias Forenses de la Universidad Nacional Autónoma de México, y fue revisado, editado y corregido por la Licda. Valeria Alexandra Alonzo Matamoros egresada de la carrera de lenguas extranjeras, de la Universidad Nacional Autónoma de Honduras. Se agradece a Claude Roux, por brindarnos su autorización para publicar la traducción al español en nuestra revista.

Mariam Vashakidze

International and Georgian legislation recognises the priority of protecting a child's best interests. While discussing any issues related to a minor, the discussion starts by considering the best interests. The present article relates to protecting the best interests of a child in the field of healthcare when receiving medical services and the exact allocation of functions and duties of the involved decision-making parties to provide guaranteed protection of the best interests of a child. Protection of the best interests of a child includes both the immediate identification of the possible child abuse fact and any long-term interest that may influence the child’s development and psycho-emotional state. A legal representative acting on behalf of a child mainly decides on the medical services provided to the minor. Each case will be evaluated individually to guarantee the protection of a child’s rights and best interest. However, before assessing the protection of a child’s best interests in the medical field, the concept of the child’s best interests will be discussed in general. Acting within the framework of the medical legislation, medical workers play the leading role in the process of providing medical services to minors. That is why the constant involvement of the healthcare system is necessary to eliminate the gaps and barriers under consideration. To ensure the balance between parental authority and the child’s autonomous decision-making, the individual case must be evaluated, and a unified objective must be established using a multidisciplinary approach. The standard research method of the record of medical legislation clearly shows the conflict of interest occurring when considering the best interests of a child and the inevitable violation of the child’s unconditional right to be heard.

Katherine L. Kraschel, Alexander Chen, J. Turban et al.

In the past two years, in 25 US states, bills have been introduced to restrict access to gender-affirming medical care for minors. Some have already become law. We show how these bills, while purporting to “protect” trans youth, are really an assault on their ability, along with their parents’ and physicians’, to make healthcare choices and to receive medically necessary care. We discuss the evidence-based guidelines for the care of these patients, the positions taken by major medical societies against these bills, and the landscape of legal challenges that are being brought against these enacted laws.

Anna Kheyfets, Shubhecchha Dhaurali, Paige Feyock et al.

The growing restrictive abortion policies nationwide and the Supreme Court decision on Dobbs v. Jackson Women’s Health Organization place increasing barriers to abortion access in the United States. These restrictions disproportionately affect low-income people of color, immigrants, and non-English speakers, and have the potential to exacerbate already existing racial inequities in maternal and neonatal outcomes. The United States is facing a Black maternal health crisis where Black birthing people are more than twice as likely to experience maternal mortality and severe maternal morbidity compared to White birthing people. Restrictions creating geographic, transportation, and financial barriers to obtaining an abortion can result in increased rates of maternal death and adverse outcomes across all groups but especially among Black birthing people. Restrictive abortion laws in certain states will decrease already limited training opportunities in abortion care for medical professionals, despite the existing abortion provider shortage. There is an immediate need for federal legislation codifying broad abortion care access into law and expanding access to abortion training across medical education. This commentary explores the impact of restrictive abortion laws on the Black maternal health crisis through multiple pathways in a logic model. By identifying current barriers to abortion education in medical school and residency, we created a list of action items to expand abortion education and access.

Khamis Al-alawy, I. Moonesar

The World Health Organization describes health innovation as developing new or improved systems, policies, products, technologies, services or delivery approaches that improve health and well-being, specifically of vulnerable people. The study’s objectives were to (a) explore the legislative and regulatory journey of telehealth across the Organisation for Economic Co-operation and Development and non-Organisation for Economic Co-operation and Development countries and (b) provide recommendations to strengthen health system performance. We reviewed information sources for Organisation for Economic Co-operation and Development and non-Organisation for Economic Co-operation and Development countries opportunistically, including government and medical board publications, media coverage and peer-reviewed papers, to provide a perspective on the legislative and regulatory telehealth journey. Our review of countries suggests that legislation and regulation remain essential for governance, accountability and assuring that healthcare professionals and technologies are safe and secure. However, there was no uniform approach to telehealth legislation and regulation, and the precautionary approach was observed in some countries. Different strategies appear to have been adopted for telehealth implementation. There is a need to go beyond legislation and regulation to strengthen health system performance and assure the future success of telehealth services. Health system decision makers should work with health system stakeholders to strategise and plan for telehealth services as it will have implications on the future delivery of healthcare services and the health system. Further research is needed to explore how policy frameworks may support innovations in healthcare, such as telehealth.

P. Gupta, Ellis P. Barrera, Elizabeth R. Boskey et al.

Abstract Context Access to gender-affirming medical care is associated with better mental health outcomes in transgender and gender diverse youth. In 2021 and 2022, legislation aiming to ban gender-affirming medical care for youth was proposed in 24 states. Objective This study aimed to (1) assess the impact of this legislation on pediatric providers based on legislative status of their state of practice and (2) identify the themes of concerns reported by them. Methods A mixed-methods study was conducted via an anonymous survey distributed to pediatric endocrinology providers. Survey responses were stratified based on US state of practice, with attention to whether legislation aiming to ban gender-affirming care had been considered. Data were analyzed both quantitatively and qualitatively. Results Of 223 respondents, 125 (56.0%) were currently providing gender-affirming medical care. A total of 103 (45.7%) respondents practiced in a state where legislation aiming to ban gender-affirming care had been proposed and/or passed between January 2021 to June 2022. Practicing in legislation-affected states was associated with negative experiences for providers including (1) institutional pressure that would limit the ability to provide care, (2) threats to personal safety, (3) concerns about legal action being taken against them, (4) concerns about their career, and (5) institutional concerns about engagement with media. Major qualitative themes emerging for providers in legislation-affected states included safety concerns and the impact of laws on medical practice. Conclusion This study suggests that legislation aiming to ban health care for transgender youth may decrease access to qualified providers in affected states.

Dirk Mohn, Matthias Zehnder

A new regulation for the marketing and application of medical devices has become applicable in the European Union as of May 2021. This regulation is termed EU 2017/745 or Medical Device Regulation (MDR). Initially published and entered into force in 2017, it replaces the former Medical Device Directive 93/42/EEC (MDD), but is still under amendment. The implication of this legislation have broad effects on manufacturers, importers, distributors, users of medical devices, and patients. This article discusses the MDR from the dental perspective. As is illuminated in this text, the MDR will create more red tape for industrial players to get their products CE (Conformitée Européenne) marked, and more documentation work for dentists. This also means that smaller companies acting out of Europe are affected in a disproportionally negative manner compared to their globally acting counterparts. The MDR could and most probably will result in a considerable reduction and price increase of the products that are available to European dentists. Moreover, the MDR could create a rift between dental materials scientists working at universities and the dental industry, because the latter now has to direct more money towards regulatory affairs rather than product development or innovation. On the other hand, the MDR may also act as an antetype for similar regulations in other parts of the world, and could offer new career opportunities for individuals in dental materials research, especially in the regulatory field.

Yuni Fitriana, Ari Andriyani, Andina Vita Sutanto

Abstract: Every woman wants to have a baby safely. Delivery can be normal or Section Cesaria (SC). Midwives who experience complications are referred to by the midwife as PPK I to the PPK II BPJS Hospital. SC measures include BPJS Health capitation. The referral flow is regulated by the National Health system which is divided into first-level health services (PPK I). and advanced level (PPK II). The implementation of the referral still encountered problems in PPK II such as patient refusal. This research is a qualitative descriptive study with an empirical judicial approach, namely analyzing the process of patient referral for SC measures related to BPJS, collaboration between midwives and PPK II BPJS, obstacles and problem solving for patient referral for SC action. The results of the SC action research are based on medical indications, the referral process from PPK I to PPK II has no obstacles in accordance with the rules and uses the BPJS SISRUTE, Midwives do not get fees for referring BPJS patients in PPK II, obstacles in the form of requests for BPJS class advancement, financing claims BPJS is sometimes jammed, the patient refuses to be referred because the room is not available. Resolving these obstacles requires the socialization of BPJS regulations, regular financial management, and the maximum use of SISRUTE. Therefore the need for the Government to always improve the quality of BPJS services with clear regulations. Abstrak: Setiap perempuan ingin melahirkan bayi dengan aman. Persalinan dapat secara normal atau Section Cesaria (SC). Persalinan yang mengalami penyulit dirujuk Bidan sebagai PPK I ke Rumah sakit PPK II BPJS. Tindakan SC termasuk kapitasi BPJS Kesehatan. Alur rujukan diatur oleh sistem Kesehatan Nasional yang terbagi menjadi pelayanan Kesehatan tingkat pertama (PPK I). dan tingkat lanjutan (PPK II). Pelaksanaan rujukan tersebut masih menemui masalah di PPK II seperti adanya penolakan pasien. Penelitian ini merupakan penelitian deskriptif kualitatif dengan pendekatan yudiris empiris yakni menganalisis proses rujukan pasien tindakan SC terkait BPJS, Kerjasama bidan dengan PPK II BPJS, Hambatan dan penyelesaian masalah rujukan pasien tindakan SC. Hasil penelitian Tindakan SC didasarkan pada indikasi medis, proses rujukan dari PPK I ke PPK II tidak ada kendala sudah sesuai dengan aturan dan menggunakan SISRUTE BPJS, Bidan tidak mendapatkan pembayaran tambahan (fee) dalam merujuk pasien BPJS di PPK II, hambatan berupa permintaan naik kelas BPJS, klaim pembiayaan BPJS yang kadang macet, adanya penolakan pasien dirujuk dengan alasan ruangan tidak tersedia. Penyelesaian hambatan tersebut perlunya sosialisasi aturan BPJS, manajemen keuangan yang teratur, penggunaan SISRUTE secara maksimal. Oleh karena itu perlunya Pemerintah selalu melakukan peningkatan kualitas pelayanan BPJS dengan regulasi yang jelas.

Asmin Sahari

Abstract: Indonesia is a state of law, where almost all provisions must be contained in the legislation. In the health aspect, it is also inseparable from the legal aspect, one of which is circumcision. Circumcision is a medical and invasive procedure whose implementation and evaluation are monitored by experts and professionals. In this study, I raised several matters of health law in it, namely, Do All Health Workers Have the Competence to Perform Circumcision Actions according to health law? The purpose of this study was to determine the juridical aspects of the circumcision of boys by doctors at the service as well as liability in the event of a home or even death. This research method is normative juridical. This article describes various problems related to circumcision as well as legal aspects related to male circumcision. Based on the results of a literature study, the authority for circumcision in boys is only with doctors, this is evidenced by the 2012 Indonesian Doctor Competency Standards which become competency level 4A, namely, doctors can carry out circumcision actions independently. The authority for circumcision can be delegated from doctor to nurse through a mandate, provided that the recipient of the mandate is a competent person in the field of circumcision, so there needs to be an institution that issues circumcision competencies for the nurse so that doctors can only delegate authority to competent nurses. Keywords: Competence, Circumcision, Health Law   Abstrak: Indonesia sebagai Negara hukum, dimana hukum semua ketentuan  harus termaktum dalam perundang-undangan. Dalam aspek kesehatan juga tidak lepas dari aspek hukum, salah satunya adalah tindakan sirkumsisi.  Tindakan sirkumsisi adalah tindakan medis dan bersifat invasif yang pelaksanaan dan evaluasi dipantau oleh tenaga ahli dan professional. Pada penelitian ini saya mengangkat beberapa isu hukum kesehatan didalamnya, yaitu  Apakah Semua Tenaga Kesehetan Memiliki Kompetensi Melakukan Tindakan Sirkumsisi Menurut hukum kesehatan?Bagaimana Kewenangan Tenaga Kesehatan Dalam Tindakan Sirkumsisi Di Layanan kunjungan rumat ? tujuan penelitian ini adalah mengetahui aspek yuridis pada tindakan sirkumsisi anak laki-laki oleh dokter di layanan rumah serta pertanggungjawaban dokter apabila terjadi kecacatan atau bahkan kematian. Metode penelitian ini adalah yuridis normatif.  Artikel ini menjelaskan berbagai permasalahan berkaitan dengan tindakan sirkumsisi serta aspek hukum yang berkaitan dengan layanan sirkumsisi laki-laki. Berdasarkan hasil studi kepustakaan, Kewenangan tindakan sirkumsisi pada anak laki-laki  hanya ada pada dokter, ini dibuktikan dengan Standar Kompetensi Dokter Indonesia tahun 2012 yang menjadi komptensi tingkat 4A yaitu dokter mampu melaksanan tindakan sirkumsisi secara mandiri. Kewenangan tindakan sirkumsisi dapat dilakukan pelimpahan dari dokter kepada perawat melalui delegasi, dengan syarat penerima delegasi adalah orang kompeten di bidang sirkumsisi, sehingga perlunya ada lembaga mengeluarkan sertifikat kompetensi sirkumsisi untuk perawat sehingga dokter hanya dapat melimpahkan kewenangan kepada perawat yang berkompeten. Kata Kunci : Kompetensi, Sirkumsisi, Hukum Kesehatan

Sky Wei Chee Koh, Hwei Ming Tan, Wayne Han Lee et al.

Background: COVID-19 booster uptake remained poor among healthcare workers (HCW) despite evidence of improved immunity against Delta and Omicron variants. While most studies used a questionnaire to assess hesitancy, this study aimed to identify factors affecting booster hesitancy by examining actual vaccine uptake across time. Method: COVID-19 vaccination database records among HCW working at seven Singaporean public primary care clinics between January to December 2021 were extracted, with sex, profession, place of practice, vaccination type, and dates. Time to booster was calculated from the date of vaccination minus date of eligibility. Chi-square test was used to compare the relationship between first dose and booster hesitancy, Kaplan–Meier method and log-rank test were adopted to evaluate differences in cumulative booster uptake. Multivariate Cox regression was used to investigate predictors for timely booster vaccination. Vaccination rate was charted across time and corroborated with media releases pertaining to legislative changes. Results: A total of 877 of 891 (98.9%) primary care HCW were fully vaccinated, 73.8% of eligible HCW had taken the booster. HCW were less booster hesitant [median 16 (5–31.3) days] compared to the first dose [median 39 (13–119.3) days]. First dose-hesitant HCW were more likely to be booster hesitant (OR = 3.66, 95%CI 2.61–5.14). Adjusting for sex, workplace, and time to first dose, ancillary (HR = 1.53, 95%CI 1.03–2.28), medical (HR = 1.8, 95%CI 1.18–2.74), and nursing (HR = 1.8, 95%CI 1.18–2.37) received boosters earlier compared with administrative staff. No temporal relationship was observed between booster uptake, legislative changes, and COVID-19 infection numbers. Conclusion: Vaccine hesitancy among HCW had improved from first dose to booster, with timely booster vaccination among medical and nursing staff. Tailored education, risk messaging, and strategic legislation might help to reduce delayed booster vaccination.

James I. J. Green

The 1990s saw the introduction of three European directives that aimed to harmonise medical device legislation within the European Union (EU), which were given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618). Dental professionals who prescribe and manufacture custom-made devices were required to do so in accordance with the relevant requirements of one of these directives, Council Directive 93/42/EEC (Medical Device Directive [MDD]). The MDD has been replaced by Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]) and this paper answers some important questions regarding the ways in which this affects the provision of custom-made devices in a dental setting. Examines the background to medical device legislation pertinent to custom-made devices. Considers the impact that the UK's withdrawal from the EU and the COVID-19 pandemic has had upon the new Medical Device Regulations. Highlights the obligations that relate to dental professionals who prescribe and manufacture custom-made devices. Examines the background to medical device legislation pertinent to custom-made devices. Considers the impact that the UK's withdrawal from the EU and the COVID-19 pandemic has had upon the new Medical Device Regulations. Highlights the obligations that relate to dental professionals who prescribe and manufacture custom-made devices.

Rajkumar Cheluvappa, Selwyn Selvendran

Background Law entails precedent-based common law and parliamentary-legislation-based statutory law. Australian courts recognise civil wrongs, called torts. The most common tort worldwide is negligence. The first aim of the paper is to educate the Australian nursing community about medicolegal issues, statutes, important cases, legal applications, and negligence statistics pertaining to clinical practice. The second aim is to determine whether medicolegal negligence claim-numbers are commensurate with recorded statistics on adverse events. The third aim is to determine and discuss preventative approaches to minimise culpability. Materials and methods Relevant searches were done using Pubmed, Google Scholar, and Austlii. Data, negligence legislation, key cases, and law processes were collated and analysed based on court decision citations, legal impact, and relationships between legislation application and case law. Although New South Wales legislation was used throughout this paper, parallel statutes exist across Australian jurisdictions. Results The basics of the civil tort offence of negligence are explained with step-by-step explanations. Key judgments and application of legislation in key medical negligence cases are discussed. Relevant medicolegal issues and negligence statistics are discussed. The civil tort of negligence is elaborately discussed, step-by-step, with relevant Common Law and legislation relevant to NSW. The watershed cases of Hadiza Bawa-Garba and Nurse Amaro are summarised with the ramifications for doctors and nurses. Expedient strategies to assist doctors and nurses in minimising unlawful action are discussed. Conclusions Adverse medical events are high in Australia. However, new claims are decreasing. Negligence claim-numbers are disproportionate to statistics on adverse events. The Hadiza Bawa-Garba and Nurse Amaro cases have opened a legal can of worms with manifold negative ramifications for the nursing community.

A. Drongelen, A. D. Bruijn, B. Roszek et al.

Mildred Alvarenga

La Genética Forense es una especialidad de la genética que actualmente ocupa un lugar preferencial por su gran utilidad para identificar personas, esclarecer casos criminalísticos o de filiación genética, sobre todo en casos en los que no se cuenta con muestras adecuadamente conservadas; por ejemplo, en la identificación de restos óseos. En Honduras la genética forense se viene utilizando desde el año 2002, cuando la Dirección de Medicina Forense inauguró su laboratorio de Genética Forense; y hoy ya es una herramienta plenamente consolidada y ampliamente utilizada.

Hyder, Maryam A, Razzak, Junaid

Telemedicine refers to the delivery of medical care and provision of general health services from a distance. Telemedicine has been practiced for decades with increasing evidence proving its potential for enhanced quality of care for patients, reduction in hospital readmissions, and increase in savings for both patients and providers. The COVID-19 pandemic has resulted in a significant increase in the reliance on telemedicine and telehealth for provision of health care services. Developments in telemedicine should be structured as complements to current health care procedures, not with the goal of completely digitizing the entire health care system, but rather to use the power of technology to enhance areas that may not be working at their full potential. At the same time, it is also clear that further research is needed on the effectiveness of telemedicine in terms of both financial and patient benefits. We discuss the current and rapidly increasing knowledge about the use of telemedicine in the United States, and identify the gaps in knowledge and opportunities for further research. Beginning with telemedicine’s origins in the United States to its widespread use during the COVID-19 pandemic, we highlight recent developments in legislation, accessibility, and acceptance of telemedicine.

C. Maria, Licia Di Pietro, A. Lantada et al.

Abstract Objectives The principal motivation for regulating medical devices is to protect patients and users. Complying with regulations may result in an increase in development, manufacturing and service costs for medical companies and ultimately for healthcare providers and patients, limiting the access to adequate medical equipment. On the other hand, poor regulatory control has resulted in the use of substandard devices. This study aims at comparing the certification route that manufactures have to respect for marketing a medical device in some African Countries and in European Union. Methods We examined and compared the current and future regulations on medical devices in the European Union and in some countries in Africa. Contextually we proposed future approaches to open design strategies supported by emerging technologies as a means to enhance economically sustainable healthcare system driven by innovation. Results African medical device regulations have an affinity to European directives, despite the fact that the latter are particularly strict. Several states have also implemented or harmonized directives to medical device regulation, or have expressed interest in establishing them in their legislation. Open Source Medical Devices hold a great promise to reduce costs but do need a high level of supervision, to control their quality and to guarantee their respect for safety standards. Conclusion Harmonization across the two continents could be leveraged to optimize the costs of device manufacture and sale. Regulated open design strategies can enhance economically sustainable innovation.