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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.
Consensus is often the enemy of innovation.
by David A. Asch, Kevin B. Mahoney and Roy Rosin
October 28, 2019
Every week, medical journals bring us news of astounding scientific discoveries: CRISPR gene editing, or CAR-T cell therapy for cancer. And yet just as frequently we hear, “Why can’t health care be more innovative?” The resolution of this paradox lies in recognizing that when people lament health care’s lack of innovation, they’re referring to how we deliver services to patients. That distinction makes the paradox even starker: “So, you’re telling me that you can reprogram T cells to find and kill cancer cells, but it took four months to get my mother an appointment with a neurologist; she spent two hours in the waiting room; and then she got an exorbitant bill that read, ‘This is not a bill’?”
Improving patient scheduling, service, or billing should not be as hard as harnessing clustered regularly interspaced short palindromic repeats to edit nucleotide sequences. And yet it seems to be. Why is that, and what can we do about it?
A big difference between innovating in the molecular sciences and in care delivery is that molecules don’t fight back. Bacteria may exchange plasmids, but they don’t practice guile. Nor do they take comfort in doing things the way they’ve always been done. The resistance to change in health care is sometimes simple intransigence but mostly it is the natural byproduct of thoughtful professionals trying to avoid mistakes in a setting that is expensive, regulated, and high stakes. Yet, successful health care innovation follows the pattern of successful science; it requires laboratories where experimentation is encouraged and can proceed safely so that change seems less fraught. We’ve found that the approaches below can help support this essential kind of experiment.
Delay consensus. The CEO of an oil company has more organizational power than the CEO of a health system because the latter cannot tell the aortic surgeon how to operate any more than the aortic surgeon can tell the perfusionist how to manage the heart-lung machine. Highly-specialized expertise and narrow licensing and credentialing make health care organizations so matrixed that it seems anyone can say no, and no one can say yes.
We have been testing a program in which patients with advanced obstructive pulmonary disease alert us of exacerbations before heading to the emergency room. Using existing ride sharing services and “borrowing” the medical supply backpacks already prepared for our helicopter-based trauma team, we rapidly dispatch to patients’ homes EMT-trained nurses carrying intravenous tubing, corticosteroids, bronchodilators, and diuretics. The pilot has prevented seemingly inevitable admissions at low cost. When we describe programs like this at meetings, we often hear responses like “If I suggested that at my institution, a dozen people would tell me no.”
Traditionally, health system leaders presented with this concept would insist we first coordinate with a range of clinical and administrative services (medicine, nursing, pharmacy, finance, security)—certainly delaying and likely dooming the project from the start. Instead, when leadership’s first exposure to the new model is in the form of promising results from initial tests, conversations focus instead on to how to work out kinks, make it part of the regular business process, and scale it up.
The program might not have worked, but those risks are easier to take at lower organizational levels where getting input, which is directionally useful, doesn’t turn into requiring consensus, which is often directionless. Health care innovation requires allowing teams pursuing novel models to get started without all the permissions they will eventually need to scale what works. This isn’t about recklessly going rogue, but recognizing that small experiments offer their own safety checks when they’re stepwise and measured.
Enable exceptions. Guidelines recommend early post-partum visits to manage hypertension among women with pre-eclampsia. But clinic appointment show rates within our health system remained low despite efforts to engage this population, leaving hypertension as our leading cause of maternal rehospitalization. Our rules limited patient communication to only four channels: face to face, telephone, mail, or email transmitted through a patient portal requiring sign-in. Each of these channels is foreign to women of this age. None seemed likely to work, and none did.
The argument that we should try a text-based monitoring system with these women encountered, at that point in time, concerns that texting is not secure and reminders that it’s not allowed. Changing the request from “Can we text patients?” to “Can we try it, for a limited time, in a limited population” made it safer by bounding it in an experiment with an automatic sunset. In health care, even seemingly small exceptions to protocol create outsized concerns about setting new precedents. The gambit here is that those concerns can often be overcome with the explicit stopping criteria experiments provide. This project’s success (it more than doubled the rate of post-partum blood-pressure measurement) made it essential to continue texting. The predictions about setting new precedents came true, as texting use cases grew based on patient preference and results, but the concerns about those predictions were managed.
Free the data. The opportunities arising because health care data are increasingly digital sit alongside laments that these opportunities remain out of reach. Processes created by electronic health record (EHR) vendors and hospital information technology (IT) policies aim for scale, reliability, standardization, and security. The threat to innovation is that these processes typically lock systems down, limiting experiments that explore new ways to leverage data.
Leading health systems select clinicians and staff who can take health care to new places. Serving on the front line, and aiming to make that care better, they will always be ahead of the EHR vendors, and frustrated by standardized information systems whose upgrades solve for what most people needed in the past but not for what leading organizations need now. While clinical uses and needs should dictate design and pace, the felt experience in hospitals is often the other way around.
For us, success has required creating platforms and extensions that sit between the EHR and clinicians, allowing data manipulation and presentation in new interfaces outside of the locked down systems. It entails having a dedicated development team operating outside the IT organization and protected from the enterprise priorities of the moment to focus on opportunities of the future. Effective health care CIOs support infrastructure that makes data available for experimentation.
We had been identifying only a small fraction of medical inpatients needing behavioral health support, and even then finding them too late—resulting in high use of restraints, the need for 1:1 coverage by staff, longer hospital stays, and incomplete or delayed care. To address this challenge, the language within clinical notes was ported outside the EHR to quickly design and test algorithms for early patient identification, with automated communications to interdisciplinary behavioral health teams. With a few months of iteration and testing we were able to identify eight times as many patients with needs, deliver behavioral health consultations on day one of their stay instead of day five, decrease hours in restraints by 30%, reduce 1:1s, safety events, and patients leaving against medical advice, and cut a day from the average length of stay. Those pilot results built organizational support to refine and test further. This pace was enabled by rapid experimental iterations that would not have been possible had this work been attempted within the existing enterprise IT infrastructure.
Successful innovation requires experimentation—following many of the same pathways of the successful science that has brought us CAR-T cell therapy and CRISPR. But health care change requires we tinker with the health care system we depend on, affecting critical resources organizations understandably protect. To support the people determined to drive change quickly, we need to find ways to bend institutional norms safely.
David A. Asch
David A. Asch, MD, MBA is the John Morgan Professor at the Perelman School of Medicine and the Wharton School and Director of the Center for Health Care Innovation at the University of Pennsylvania.
Kevin B. Mahoney
Kevin B. Mahoney, DBA, is the CEO of the University of Pennsylvania Health System.
Roy Rosin, MBA, is the Chief Innovation Officer of Penn Medicine at the University of Pennsylvania.
This article originally appeared on HBR.org and is being brought to you by Medtronic.
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