The Accelerated Digital Clinical Ecosystem (ADviCE) links app vendors and health systems, for integration into electronic health records.
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Digital Health Software Tools
ADviCE is the Accelerated Digital Clinical Ecosystem, a leading digital health collaborative workspace for digital health software tools— linking patients, providers, payors, innovators, health systems, policymakers, and other stakeholders.
The Context
Digital health is here. Digital Health Software Tools are becoming increasingly available to patients, health systems, payors, and others seeking to enhance patient-centered care with innovative apps, sensors, algorithms, and data visualizations. The potential to disrupt old models of clinical work, innovate on how we identify disease and treatments, and maintain or improve health is vast and growing.
The U.S. Food and Drug Administration (FDA) has proposed to launch a new Software Precertification Program as a new regulatory paradigm and cutting-edge approach to evaluating software as a medical device before it enters the marketplace.
The range of digital health software tools, however, is far broader and wider reaching. ADviCE is here to help!
The Challenge
Health systems and patients want tools that are effective, safe, and easy to use but don’t have a way to identify them. Companies and innovators with promising digital tools struggle with workflow and technical needs of their potential users. The combination of these factors slows innovation and improvement in care.
The Accelerated Digital Clinical Ecosystem (ADviCE) catalyzes rapid improvements in healthcare in an ecosystem of curated digital health tools linking digital health innovators to health systems and healthcare providers.
Mission & Vision
ADviCE allows healthcare providers to identify which digital tools are appropriate for which patients, how to add them to busy clinical lives, and—most importantly—which tools are safe and effective.
ADVICE supports and spreads best practices for innovation in healthcare by sharing experiences within our consortium and with the public ADviCE supports best practices for implementing and evaluating the use of digital software in practice through sharing experiences within our consortium and with the public.
Focusing on understanding, measuring, and evaluating how digital health software tools (DHSTs) perform in real-world settings, relying on the increasing amount of rich clinical, patient, and other data available from DHSTs as well as electronic health records to catalyze continuous innovation in patient-centered care.
ADviCE supports the real-world adoption of Digital Health Software Tools (DHSTs) upon entry into the marketplace and includes DHSTs that are the focus of the FDA’s Software Precertification program as well as others.
Although the FDA’s Software Precertification Program is focusing on higher risk DHSTs, software as a medical device (SaMD), health systems and patients are faced with a far broader range of DHSTs in real life.
Digital Health Common Application (DHCA)
The Digital Health Common Application collects simple, but critical information needed for health systems and vendors to connect.screening, selecting, integrating, and evaluating DHSTs.
The DHCA provides a standard set of questions frequently asked of vendors by stakeholders such as health systems, patients, and others to assess a DHST before possible integration and use.
Health systems, vendors, and other key stakeholders report that developing a common lexicon and disclosure of information would facilitate the adoption and use of DHSTs.
There is wide variation in how health systems approach the adoption of new software, and vendors often don't know what to expect when embarking on an integration project. The ADviCE Adoption Framework creates transparency around what vendors should expect and frames collaboration between health systems seeking to streamline complex processes.
Do digital tools do what they say they do? ADviCE will help derive insights from information gathered by participants to define performance across the healthcare ecosystem. Our collaboration is building a framework grounded in clinical expertise and research to identify and collect real-world performance data that best measure the effectiveness and safety of DHST in practice.
What is a Digital Health Common Application for Digital Health Software Tools?
The Digital Health Common Application (DHCA) is a standard intake survey which vendors and innovators complete to pre-answer many of the common questions that arise during initial considerations of integrating Digital Health Software Tools into clinical care.
In our experience, common questions include vendors’ past experiences integrating with specific vendor EHRs, and whether they require HL-7 programming to achieve integration.
The ADviCE DHCA establishes consistent, shared, standards of expectations and disclosure among vendors, health systems, patients, and other stakeholders.
Why is a Digital Health Common Application needed?
Health systems spend hundreds of hours in software acquisition activities each year, while vendors marketing budgets are often spent simply trying to understand how to collaborate with potential customers.
The DHCA can streamline collaboration by providing common steps for evaluation of Digital Health Software Tools, and forming a single front door for contracting processes.
What is the value of the Digital Health Common Application to health systems, vendors, and stakeholders?
For health systems, they can expect to have vendors approach them with clearly articulated, standardized, and consistent information about their company, their specific Digital Health Software Tool, and its ability to integrate into care delivery.
Vendors can anticipate and identify topic areas important to health systems in advance, ensuring they are prepared before approaching a health system.
Example of DHCA Elements
What are the checklist elements intended to do?
The ADviCE Adoption Framework is a list of recommendations that should be considered as organizations consider potential solutions and plan to integrate them into practice.
Information collected will define shared understanding around the path to adoption and lower the friction inherent to the process of selecting, purchasing or recommending, and using digital health tools effectively.
ADviCE will not recommend or develop technical standards for integration. Approaches used may be shared across ADviCE, but other, technically-minded societies and agencies are better suited to defining technical standards.
The ADviCE Adoption Framework is a list of recommendations that should be considered as organizations consider potential solutions and plan to integrate them into practice.
Information collected will define shared understanding around the path to adoption and lower the friction inherent to the process of selecting, purchasing or recommending, and using digital health tools effectively.
ADviCE will not recommend or develop technical standards for integration. Approaches used may be shared across ADviCE, but other, technically-minded societies and agencies are better suited to defining technical standards.
Why is the checklist needed?
As DHSTs grow in number and complexity, and as risks around data loss remain to be fully delineated, setting best practices is useful to vendors, consortium members, and stakeholders by
1) Setting shared expectations around process points important to sites and vendors,
2) Setting shared understanding around common areas of sensitivity for sites and vendors, and
3) Allowing sites and vendors with less experience in the evaluation and implementation of DHSTs to more rapidly develop effective working relationships.
For vendors and health systems, this approach means ADviCE will be able to define variations in expectations and capabilities on both sides, the variation that may, in turn, be useful targets for collaboration.
Setting standard expectations for implementation also sets market conditions that will facilitate more effective collaboration. Sharing these practices widely will further accelerate technical advances, though this is not a primary function of ADviCE.
Example Checklist Elements
Why are real-world data important to ADviCE?
Real world data (RWD), as opposed to randomized trial data, are collected during the provision of clinical care and collected observationally.
These sorts of monitoring strategies — while subject to the challenges and messiness of observational data — represent actual care delivered. In the context of ADviCE, there are a number of benefits to collecting and sharing RWD for ADviCE members:
What do RWD in ADviCE look like?
Clinical Outcomes | User Outcomes | Product Outcomes | Context and Site-level Data | |
|---|---|---|---|---|
Implementation Data | · Baseline clinical process and/or outcome statistics · Baseline adverse event rate (if applicable) | · Training requirements · Feedback from users/sites | · Changes made on behalf of the site by vendors · Rating of the site’s pre-launch services | · Implementation checklist steps carried out · Confirmation that launch occurred |
Longitudinal Data | · Clinical process and/or outcome statistics · Adverse event rate (if applicable) | · Results of break-fixes and issue resolution · Feedback from users/sites | · Usage statistics/downloads · API traffic · Data security breaches or changes in security processes · Version | · Changes in EHR or other local contexts · Ratings of interactions between site/vendor · Whether or not tool has been retired |
What do RWD in ADviCE look like?
Karoliina Yang
Founding Fellowship Program Director
Pamela Lagera
Fellowship Program Director
Patricia Martell
Fellowship Program Director
Adrianna G Tan
Ally Seba
Anaya Desai
Andrea Bolanos
Arlin Khan
Asim Mohamed
Brandon Sun
Devashri Joshi
Gift Nwagu
Hannah Nelson
Harini Adivikolanu
Kay Hung
Kevin Cody
Safa Ahmad
Saipriya Metla
Shivang Trivedi
Shwetha Bindhu
Vyoma Trivedi