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Medtronic, Inc. (“Medtronic”) offers RemoteView, which permits a user (“Programmer User”) of the Medtronic CareLink® 2090 Programmer (“Programmer”) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (“Remote Viewer”), including remote health care professionals or Medtronic representatives.
Limited License Grant. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. You shall have sole responsibility for any fees or charges, including service or data charges, incurred by you in connection with your use of the Licensed Software. You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation.
Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
“Active Remote Viewer” as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software.
By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User:
) Registration. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. All information that you provide in connection with such registration must be complete, accurate, and truthful. The user name and password are personal to you and must not be shared with anyone else. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password.
) Your Personal Information. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. You agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America.
) Session Key. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. “Session Key” as used herein means a unique token active for a limited period of time generated by the Remote Viewer. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session.
) Logging of Session Activity. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America.
) Active Remote Users. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information.
) Availability. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time.
Permissions. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software.
Your Acknowledgements. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patient’s implanted cardiac device data, including any data on the Programmer. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients.
Security/Privacy of Patient Data. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information.
Reporting Issues and Feedback. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. If you submit any comments or ideas to Medtronic, in the absence of a separate agreement regarding such submissions, you grant to Medtronic an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such ideas in any medium and agree that Medtronic is free to use them for any purpose. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Any maintenance and support services provided by Medtronic shall be at Medtronic’s sole discretion.
Limitations of Liability.
THE LICENSED SOFTWARE IS PROVIDED TO YOU “AS IS,” AND MEDTRONIC EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE AND YOUR USE THEREOF, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE.
Legal Compliance. You shall at all times use the Licensed Software in compliance with all applicable laws. You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a “terrorist supporting” country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties.
Term, Termination, Modifications, and Support. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Medtronic may modify, amend, or terminate this Agreement at any time, including by providing notices or an updated version of this Agreement on a Medtronic website. Medtronic may modify, disable, or terminate your use or Medtronic’s support of the Licensed Software at any time, including by providing notices on a Medtronic website. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. At any time upon Medtronic’s request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. In addition, upon Medtronic’s request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction.
NayaMed International Sárl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Sárl. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses.
Case study examining the role of health technology assessment, the success of telemedicine, and areas needing improvement.
Over the past 15 years, México has been making significant progress on increasing healthcare coverage for its low-income population. Underpinned by a structural reform passed in 2003, México has increased healthcare spending and expanded coverage. The national subsidised health plan Seguro Popular (Popular Insurance) now benefits more than 50m citizens (about 45% of the total population) who were previously uninsured as well as those who continue to lack formal employment. The country has also achieved world-class prevention practices; infant and maternal mortality rates have decreased, while life expectancy has risen to just under 75 years.1
Nevertheless, the health system continues to feature many areas of low levels of effectiveness, equity and responsiveness. Currently, there is a wide range of sub-systems with their own operating rules and, subsequently, uneven results, which adds complexity to policymakers’ response to address subsisting deficiencies. Budget restrictions also remain a challenge, and the government’s 2.8% share of GDP spent on healthcare is among the lowest of countries in the Organisation for Cooperation and Economic Development (OECD).2
To date, progress towards a value-based healthcare (VBHC) system has also not been a priority for Mexican policymakers. Despite important achievements in collecting epidemiological data, there is no comprehensive, standardised data on health outcomes and interoperable health records, which would facilitate monitoring and improvement in the quality of healthcare services. “The value-based healthcare approach in México is just starting to emerge,” says Eduardo González-Pier, visiting fellow at the Center for Global Development — an independent “think-and-do tank” that works to reduce poverty in developing countries — and a former deputy minister of health in México. “We are better than we were a decade ago, but we are not better than others in Latin America, and we have a lot to learn [regarding VBHC],” he adds.
Mexican policymakers are prioritising improved access to healthcare, equity and greater financial protection, mainly by reducing out-of-pocket expenses.
Yet many organisations are supporting the move towards VBHC, such as Fundación Mexicana para la Salud, a think-tank that has been promoting quality measurements and standardisation across public and private hospitals, and Fundación Carlos Slim Salud, a non-profit health organisation that has been pioneering better use of technology and health registries to improve care at reduced costs.
Meanwhile, Mexican policymakers are prioritising improved access to healthcare, equity and greater financial protection, mainly by reducing out-of-pocket expenses. Indeed, in the context of limited financial resources, one key element to improve efficiency in the use of federal funding for the Seguro Popular is the assessment of technologies applied to health services, a task that the Ministry of Health assigns to the Centro Nacional de Excelencia Tecnológica en Salud (CENETEC, the national centre of technological excellence in health).
CENETEC is leading efforts to improve the allocation of federal funds to support the operation of the Seguro Popular, by working in fields such as the assessment of medical technologies, the issuance of guidelines and the promotion of telemedicine.
According to the World Health Organisation (WHO), health technology assessment (HTA) “refers to the systematic evaluation of properties, effects, and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology. The main purpose of conducting an assessment is to inform a policy decision making.”3 Hence, by definition, HTA is an invaluable tool to advise policymakers on the most cost-efficient emerging health technologies.
CENETEC acts as one of the few HTA agencies in Latin America, only comparable to similar bodies in other large regional economies, such as Brazil and Colombia. The institution was established in 2004 and has four core activity areas:
CENETEC’s staff is primarily comprised of doctors and biomedical engineers. The agency conducts HTAs mainly at the request of public entities involved in the sector, though it can also start them on its own if a particular technology is believed to have a significant impact on the healthcare system. The evaluation of technologies is followed by the issuance of a certificate to allow their use.
To accomplish its tasks, CENETEC has an active exchange with different actors in the healthcare system. As Mr González-Pier explains, “the institution interacts with doctors and nurses, who are key for the development and monitoring of CPGs, whereas interaction with manufacturers and distributors of medical devices and equipment is key to stimulate the accomplishment of minimum technical standards.”
Inspired by guidelines from the WHO and the Pan American Health Organisation, and under pressure from technological disruptions, in 2013 the Mexican government launched the Programa de Acción Específico (PAE) para la Evaluación y Gestión de Tecnologías para la Salud 2013-2018, a specific action plan for the assessment and procurement of health technologies.4 The plan aims to promote the evaluation of health technologies, improve fairness in the allocation of funds by generating and disseminating information on the most cost-effective technologies, develop and apply CPGs, and monitor the use of technologies applied in healthcare services, including telemedicine. Doing so is critical to ensure that the healthcare sector can contain costs while directing available resources toward quality of care.
According to CENETEC, the PAE has been efficient in establishing methodologies for HTA procedures involving different actors in the health services chain.5 In the 12 months to August 31st 2018 CENETEC performed 56 HTAs on medicines and medical devices and authorised 48 CPGs6 (bringing the total number of guidelines to 815 since the entity’s creation). During this time it also continued to lead an inter-institutional committee that conducted three HTAs on medical procedures with a high impact on the national health service, including in the areas of dialysis and hepatitis C.7 “CENETEC has been successful in establishing national leadership in HTA, CPGs, management of medical equipment, and telemedicine,” says Mr González-Pier.
CENETEC’s role in the standardisation of medical equipment specifications allows better resource allocation and the universalisation of equipment use.Dr María Elena Álvarez Lobato, co-ordinator of High Specialty Hospitals at the Health Department of the State of México
Dr María Elena Álvarez Lobato, co-ordinator of High Specialty Hospitals at the Health Department of the State of México, notes that “CENETEC’s role in the standardisation of medical equipment specifications allows better resource allocation and the universalisation of equipment use.” Furthermore, according to Dr Álvarez Lobato, the agency has an important impact on the private sector’s operations. “It positively is a reference point, because they set benchmarks for costs and specifications, which are closely followed by the private providers,” she adds.
Due in part to CENETEC’s efforts to generate guidelines, criteria and work with other public entities, México has become a regional leader in the use of telemedicine. And the agency’s HTA is the basis for equipment use such as robotics in telemedicine, says Dr Mónica Armas Zagoya, deputy director of Telehealth and Information at the Health Department in the state of Zacatecas.
CENETEC’s telemedicine promotion is one example of bringing VBHC to a broader population that, although covered by the Seguro Popular, has difficulty accessing specialised service. “Robotic units are key in remote areas, because they replace the specialist or even the surgeon,” says Dr Armas Zagoya.
By working with other federal agencies, regional governments and universities, CENETEC has contributed to more widespread use of telemedicine. In the State of México alone, Dr Álvarez Lobato explains, this has led to the adoption of teleconsultation in 25 hospitals and the use of robots for critical areas such as intensive therapy, surgery and emergency rooms, as well as surgery in remote locations.
An OECD assessment on México’s health system8 generally recommends improving HTA in the country to achieve “sustainable and efficient health care funding in the future”. The OECD also believes that CENETEC should widen its role so that its recommendations can be applied not only to new treatments but also existing ones. In addition, it recommends that the agency expand its activities to directly impact other insured citizens, beyond those affiliated with the Seguro Popular. This, however, the OECD notes, “will require increased investment, and (possibly) a modification of its (the agency’s) legal status,” which will be challenging for policymakers. Finally, the OECD calls for an independent CENETEC, thus removing its affiliation with the health ministry.
Similarly, Mr González-Pier agrees on the need to expand and strengthen CENETEC’s role. He also emphasises the “importance that HTAs shall encompass more medicines,” not just medical devices. Furthermore, he sees room for improvement by collecting more data on the actual use of devices, medicines and treatments, as opposed to just assessing their future use. Finally, he underscores the need for improved governance at CENETEC and having it gain more independence and budget autonomy.
Dr Álvarez Lobato, meanwhile, thinks that CENETEC has made important progress on speeding up the average timespan that it requires to complete HTAs, but it could further reduce such timelines if, for example, it can expand its personnel to include more doctors and financial analysts. In addition, Dr Armas Zagoya believes that CENETEC’s “vital role” in fostering telemedicine can be amplified if the states could be guided by a standard governance code for e-health services. Currently, taking advantage of CENETEC’s role in the promotion of telemedicine responds more to the local vision of each state and governor, rather than to a national strategy.
Going forward, CENETEC and the usage of value-based healthcare in México may change based on the actions of the nation’s new administration of president Andrés Manuel López Obrador (AMLO), who took office on December 1st 2018.
“On one hand, the intended downsizing of staff and reduction in pay might make it difficult for the Ministry of Health to find and/or retain the necessary talent to further strengthen CENETEC,” says Mr González-Pier. “On the other hand, to the extent that the new administration is capable of unifying the health system and, in particular, the stewardship function of the ministry, CENETEC could find an unusual opportunity to position itself as the HTA agency for the broader health system.”
Dr Álvarez Lobato adds that there’s potential to end the fragmentation of work that currently exists within CENETEC and the broader health system, which can lead to better delivery of value-based healthcare.
“If the AMLO administration wants to make the different areas and entities under the ministry more efficient, it must first create multidisciplinary teams that evaluate projects in an integral way — such as from the construction of a hospital, to its equipment, its operating expenses, etc — so that the limited funds that the country has can be optimised,” she says. “CENETEC’s overall role under AMLO’s health policy must be to continue existing, perhaps under a new name, but, I insist, as part of a model of an integral evaluation of technologies and resources.”
A case study from The Economist Intelligence Unit commissioned by Medtronic.
OECD. 2016. Reviews of Health Care Systems: México 2016. http://dx.doi.org/10.1787/9789264230491-en
Secretaría de Salud de México, CENETEC. 2013. Programa de Acción Específico. Evaluación y Gestión de Tecnologías para la Salud. Programa Sectorial de Salud 2013-2018. https://www.gob.mx/cms/uploads/attachment/file/271143/PAE_2013-2018_CENETEC_13mayo2015_v31.pdf
Secretaría de Salud de México, CENETEC, 2013.
Some of the recent guidelines pertain to prevention, diagnosis and treatment of illnesses such as leukaemia, cervical cancer, Hodgkin lymphoma in children and coronary disease.
CENETEC. 2018. 6º Informe de Gobierno Secretaría de Salud Actividades del CENETEC. https://www.gob.mx/salud/cenetec/articulos/6-informe-de-gobierno-secretaria-de-salud-actividades-del-cenetec-174122
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