The new Digital Healthcare 2021 guide covers 14 jurisdictions. The guide provides the latest legal information on the impact of COVID-19, digital healthcare and climate change, software as a medical device (SaMD), telehealth, the internet of medical things (IoMT), 5G networks, artificial intelligence (AI) and machine learning, cloud computing and intellectual property (IP).
Last Updated: June 30, 2021
Accelerating advances in digital healthcare require accelerated innovation in healthcare technology agreements. Updated and new agreements are required to use key digital healthcare technologies. These include connected devices that make up the Internet of Medical Things (IoMT), wearable technology, 5G wireless networks, data analytics and machine learning, and new types of medical devices.
Wearable technology (wearables) are devices worn by individuals and sensors that attach to the skin and continuously monitor physical conditions and collect data in combination with smartphones. 5G networks are fifth-generation wireless networks that will replace the current 4G (fourth-generation) networks and bring significantly greater speed, greater bandwidth and reduced latency, all of which means that more and richer data can be transferred in the same amount of time. Connected devices and wearables generate volumes of data that 5G can transmit between devices and the hospital’s general IT systems. Together with other data sources, these technologies generate new types of data that increase the utility of machine learning and data analytics. For convenience, healthcare systems and other healthcare institutions will be referred to as “hospitals.”
This article proposes a new paradigm for structuring data use and data sharing called “decision rights,” which is discussed below. Decision rights is designed to address the current difficulties of allocating ownership and rights of use in current contract negotiations.
“Digital healthcare” will become just “healthcare." This transition will occur as digital healthcare technologies and procedures are integrated into almost all fields of medicine. This article addresses how technology and data agreements should change today to accommodate the changes brought by digital healthcare technologies, both before and after this transition.
Technology Trends to Address in Healthcare Technology Agreements
Traditional healthcare technology agreements should be re-structured to meet the digital healthcare objectives of healthcare technology companies that develop and sell digital healthcare products and the objectives of the hospitals that buy these products. In addition, most digital healthcare agreements are combined technology and intellectual property agreements which are then subject to a regulatory overlay.
Technology trends that are changing the nature of healthcare agreements include:
Using Upgraded Digital Healthcare Technology Agreements to Address these Trends
The first step to address these trends is to determine what computing power and capabilities are needed to address the above trends and then conduct a “gap analysis” to determine the shortfalls in existing systems. Then a plan should be developed to determine whether and how to revise existing contracts or enter into new ones to close the gaps. An upgrade path should be developed to expedite the adoption of the new digital healthcare technologies on the horizon.
Addressing these issues at a high level, for both healthcare technology companies and hospitals, the following should be covered by technology agreements.
Proposed Paradigm: “Decision Rights”
In practice, it is difficult to reach an agreement on data-sharing rights because the parties dispute the scope of ownership, and intellectual property rights can be unclear given the current state of the law. The parties are also concerned that they may be prejudicing data rights they may need in the future. In addition, they are concerned that, by giving up rights, they may be foreclosing revenue in healthcare and other industry sectors. If the focus is shifted from ownership to data use, because that is often the real issue involved, a legal framework will be needed to govern the scope of use and sharing, with particular attention given on protecting both providers and users of data sets.
This article proposes “decision rights” as that legal framework. A useful definition of "data" is “something that happened.” “Using” data means taking an action based on what is learned from “what happened.” This includes machine learning. Decision rights is a licensing model that defines the purpose of conducting analytics and the use of the results in terms of decisions that can be made based upon them. The model also provides the entity controlling the data with a mechanism to grant (and enforce) rights in the same data it provides to different users for different purposes, thus enhancing data-monetisation and revenue-generation. Decision rights protect against regulatory sanctions by putting boundaries on the data use that constrain the rights of use on downstream parties. Under a decision rights framework, those entities owning or controlling a database would grant a set of rights defined by the decisions that can be made, and if desired, limit the rights to a business unit or even a specific individual. This framework applies to all industries. The following example is a digital healthcare scenario.
As an example, Hospital No 1 uses robots to patrol the halls to locate areas that need emergency cleaning. The images captured by the robots incidentally capture patients' beds lined up in the hallways awaiting entry into operating rooms and/or transfer between operating rooms and the recovery rooms. Hospital No 2 seeks to optimise patient transfer and optimisation of the use of the operating room by eliminating bottlenecks and reducing the time patients spend out of their hospital rooms and spend waiting in staging areas. Hospital No 1 can grant Hospital No 2 the right to use the images only for the purposes previously outlined. In order to do this, Hospital No 1 could structure the right to use its images only for the purpose of analysing the image data and using that to optimise the use of its facilities. In addition, decision rights is a way to protect both Hospital No 1 and No 2 by using decision rights to control use in onward transfers of data sets created by Hospital No 2 without compromising Hospital No 1’s decisions to provide different rights to different users.
Healthcare Technology Development and Component Supply Agreements
Healthcare companies that develop healthcare technology products and services for sale to hospitals face several issues in structuring arrangements with their own suppliers. Often, these suppliers’ components and sub-assemblies are integrated into the healthcare technology company’s products. Those products may be medical devices regulated by the US Food and Drug Administration (the FDA). Complexities arise when different suppliers contribute components to sub-assemblies which are then integrated into the final product. The agreements between a healthcare technology company and its suppliers must address several key issues.
Intellectual Property Rights in Digital Healthcare Agreements
A healthcare technology company may ask a supplier to develop a completely customised component or a customised version of an existing component. The key ownership and intellectual property issues that arise are as follows.
Intellectual Property and Joint Development of Healthcare Products
Much of healthcare technology is developed through the collaborative efforts of different companies. Having joint development resulting in joint ownership can lead to adverse consequences. By US statute, one joint owner can grant non-exclusive licences to third parties without consent of the joint owner. This can result in the one party's contribution being free research and development to another party. This outcome can be avoided by proper contract-drafting.
Agreements for the Digital Healthcare Wearable Ecosystem
Wearable technology agreements cover the situation in which a patient is discharged from a hospital and given wearable technology to provide for remote monitoring to discover continued progress or the emergence of problems. The following agreements should be included in this arrangement:
Digital Healthcare and Data Mapping
A document mapping data flows provides several advantages and is instrumental in drafting agreements. First, it provides the lawyers drafting the agreements with the information they need to structure the agreement properly. This should cover the institution’s issue of the data and upstream and downstream rights in it, and should be combined with a decision rights' agreement or other data-sharing and use agreement. Second, a data map can be used to alert company engineers and software programmers when they need to obtain legal advice as to the types of consents and other agreements that need to be put in place in order to develop the commercial products. If a company has the right to use data for medical research under US law, where it is not completely de-identified, that right does not provide the right to use the data to develop a commercial product, where, generally, the data must be wholly de-identified.
Data will not govern itself. Accordingly, agreements must be put in place to control the collection, transmission, modification, and use of data, including by the internet of medical things, robots, and wearables which are designed to collect data and provide it for machine learning and data analytics. Digital healthcare technology requires upgrading or entering into new IT agreements. Cloud computing requires different forms or agreements. Digital healthcare technology provides additional avenues of cyber-attacks. Data mapping should be used in structuring data and technology agreements to minimise potential gaps between responsibilities imposed by contracts and hospital use, and how healthcare technology companies develop products and services.