Global Summit 2023

Pre-Summit Survey

To supplement the group discussions during the summit, KLAS administered a pre-summit survey on current challenges and gaps in healthcare policy and regulations. Of the 119 attendees, 72 (about 61%) responded, including healthcare organizations from 16 countries. Below are two main takeaways.

Healthcare Organizations & HIT Vendors Identify Poor Understanding of Healthcare Practices as Biggest Gap for Policymakers

All parties in healthcare face challenges related to policy and regulation, many of which can be attributed to (1) a lack of vision; (2) misalignment between policymakers, regulators, healthcare organizations, and vendors; or (3) a lack of engagement and collaboration. Many healthcare organizations and vendors feel policymakers and regulators are too prescriptive in mandating how care is provided without fully realizing the impact on caregiver workflows or the resource constraints organizations face. Funding frequently lags behind policy, leaving organizations unable to make necessary regulatory changes. Additionally, they feel policymakers misunderstand the available technology and whether it will actually produce the desired outcomes. For regulations to be effective, policymakers need to consider feedback from clinical leaders, administrators, and IT staff; focus more on desired outcomes than on requiring specific implementation methods (a common critique of the US’ meaningful use policy); and craft regulatory policies with specific, measurable outcomes.

“The realities, pressures, and workflows of daily clinical practice are not well understood by policymakers, regulatory bodies, and vendors. As a result, the vendor products as well as regulatory and policy environment have the potential to create barriers and inefficiencies to providers and patients in the course of care.” —CMIO

The Healthcare Industry Needs More Clarification on Data Sharing

Participants of all types report data sharing as the area most in need of additional policy refinement or clarification. Standards for data sharing exist, but confusion remains as to how sharing can and should occur both within and across countries (such as within the EU), and many healthcare organizations advocate for standards that create more universal understanding. Vendors hope that policymakers can develop more global standards while avoiding the high costs of country-specific development or overadaptation of these standards, which could stifle innovation. To accomplish this, many suggest that policymakers should first look to countries that have successfully implemented measures and then leverage existing technology and practices to determine realistic and effective global policies.

Respondents would also like more clarification when it comes to policies regarding the cloud and security—two topics that are inextricably connected (several of the requested cloud policies have to do with security). Many challenges in these areas are caused by varying interpretation of rules between different geographic regions or individual organizations, leading to inconsistent application and adherence by vendors and healthcare organizations. Clarification on existing data-sharing rules is limited, even as the industry is preparing for further changes, such as the forthcoming European Health Data Space.

Summit Discussions

During the summit, attendees formed small groups to discuss two main topics as they pertain to healthcare and HIT: (1) policy and regulations and (2) the cloud. The following are the takeaways from those discussions.

Policy and Regulation: Breaking Down Barriers between Policymakers, Regulators, Healthcare Organizations & Vendors

The Industry Should Encourage Cross-Organization and -Country Collaboration to Stay Aligned on Emerging Topics & Events

With many advances and changes being made in areas such as interoperability, the cloud, AI, and security, attendees expressed the desire to shift from a mentality of “knowledge is power” to “sharing is power.” They note that too much is happening in silos without sufficient communication—both within organizations as well as across the industry. Attendees, mostly from provider organizations, want more collaborative engagements and sharing spaces with less focus on sales. Organizations such as CHIME, HIMSS, and KLAS Research should work to facilitate learning and discussion around standards and best practices. To break down silos, it is essential to share content, learnings, and published resources from conferences with those unable to participate. The shared perspectives and resources should be elevated to the government level (including policymakers and regulators) and across countries and regions. techUK is a good example of a conference that brings together healthcare organizations and suppliers to talk about regulations, giving voice to both public- and private-sector organizations and vendors. Policies should emphasize centralized, cross-country opportunities for education and collaboration. Sweden and Norway exemplify good cross-country collaboration through their model of a single patient identifier, which is established to facilitate easier care collaboration across borders.

For policymakers & regulators:

While politics are necessary to make improvements in HIT, politics can also lead to difficult roadblocks. Politicians and policymakers tend to shift with the election cycles, so regulators can enable the longer-term evolution of healthcare by creating strategies that prioritize initiatives for longer than a single election cycle. Policymakers often focus on innovation, and while that is important, sometimes basic but necessary policies (like data governance) are left overlooked and underfunded, making it difficult for healthcare organizations to receive needed returns. One such area is interoperability; many want more emphasis on the adoption of global interoperability standards. There are a number of existing standards (e.g., HL7, FHIR, DICOM) that can and should be leveraged when considering global policies for interoperability.

In all areas, regulators should (1) look to adopt global standards rather than creating their own and (2) ensure adherence to those standards. The ultimate goal should be creating a health data ecosystem that empowers patients to own their data and allows for portability (both within a country and with other countries). As overregulation can impede both care and competition, regulators should create incentives to move both vendors and provider organizations toward better care. Ideally, regulators should convene stakeholders (clinicians, IT staff, and administrators) to discuss what is needed and desired. The constructed framework for solving challenges should be clear so that innovation is not stifled. Rather than solely focusing on costs, all involved should focus on facilitating better information sharing between primary care organizations, hospitals, and other care settings.

Provider Organizations, Vendors & Consultants Must Align with Policymakers by Prioritizing Goal of Improving Patient Care

Misalignment can be a result of different perspectives among groups. In healthcare organizations, IT staff may view technology as a product, while clinicians see it as a method to realize outcomes. The staff in informatics positions can help to align these two perspectives, working as a bridge during large-scale transformation projects. Both provider organizations and vendors need to amplify the perspective of nurses and physicians in informatics roles and further empower them to shape organizational, design, and road-map decisions while also helping to develop a multidisciplinary process rather than a siloed workflow. As healthcare organizations and vendors strive to align themselves better, they should all find common ground in the patient. Though the patient experience remains often overlooked in broad conversations about improving HIT, by aligning around what is best for patients, both provider organizations and vendors can be unified as they work to influence policy.

Policy Incentives Need to Align with Goals of Healthcare Organizations to Drive Technology Adoption

Throughout all industries, much of what can be achieved is determined by money, and digital health policy is not an exception. If incentives and funding are misaligned, then behavior will not change. For example, in the UK, there is much discussion on diverting patients from hospitals, but most funding is directed toward acute care; as a result, the focus is on treatment rather than prevention. Value-based care (VBC) can drive alignment between funding and behavior. In today’s healthcare environment, it isn’t easy to link all technology to VBC, but more emphasis on VBC initiatives could lead to powerful partnerships between vendors and healthcare organizations as both take on risk and, as a result, share an equal investment and mutually aligned incentives.

Respondents also note that the public tender process could be revamped to be less onerous. In areas such as Canada, Australia, and much of Europe, decisions can take years due to the strict public tendering process. While safeguarding against corruption and fiscal responsibility is important, there are opportunities to reduce the burden on healthcare organizations and vendors through a simplified process. The technology selection and approval process can be shortened through the development of frameworks that identify vendors who have already demonstrated the needed capabilities. Survey respondents also want an improved focus on clinical outcomes and patient satisfaction during change management processes. Healthcare organizations need to focus on and budget for more than just the technology implementation; they should also consider elements such as training to ensure deeper adoption and better outcomes.

Adoption of Cloud Technology in Healthcare

A major discussion during the summit was the cloud and its implications for healthcare. Earlier this year, KLAS surveyed healthcare organizations outside the US regarding their IT investment priorities. A majority of interviewed organizations had started working in the cloud to some degree; some reported a mature cloud program, others had moved some of their major clinical or financial systems into the cloud, and some had started early work into deploying a departmental solution in a public or private cloud or using a SaaS solution (e.g., Office365). The following charts were sourced from the resulting report, KLAS’ Global (Non-US) Healthcare IT Trends 2023.

Biggest Cloud Myths & What the Industry Should Do to Overcome Them (as Identified by Summit Participants)

What about Data Sovereignty & the Cloud?

In places like Europe, data sovereignty is perhaps the biggest roadblock to cloud adoption. There are strong emotions around health data independence and storing data within countries. The closed nature of some countries prevents healthcare data from moving to a cloud environment or across borders, even within the EU. Local interpretation of privacy laws (such as GDPR) varies by country, province, or even organization. As previously mentioned, the industry as a whole wants clarification on data sovereignty regulations to be increased and improved.

Best Practices for Provider Organizations Moving from Traditional Capital Expenditure Models to Operating Expenditure Models during Cloud Transitions

As healthcare organizations transition to the cloud, they will likely also transition from traditional capital expenditure (CapEx) funding models to operating expenditure (OpEx) models. However, this likely won’t happen until there are enough SaaS solutions to overcome market inertia. How soon the transition will happen also depends on location—for example, countries like Italy are moving quickly toward a transition, while countries like Germany are much further behind. Across all regions, organizations need to become adept at budgeting using both models.

For organizations evaluating cloud solutions and thus needing to change their modus operandi, the transition can be challenging, as they may be accustomed to receiving regular infusions of large sums of money. While there may not be a one-size-fits-all approach for navigating a transition from a CapEx to an OpEx model, there are a few things to keep in mind:

• An OpEx model is generally more expensive in the long run. In theory, the level of service tied to OpEx for something like SaaS should be higher (with the vendor taking on upgrades and infrastructure responsibilities), and the higher cost should be partially offset by the ability to redirect internal IT resources and reduce spending on capital expenditures.
• Depending on the contract, by leveraging an OpEx model for a SaaS solution, an organization could theoretically plan the next 10 years of system expenses and thus avoid surprise costs tied to upgrades and infrastructure. As part of the budget, organizations should include egress fees, which can add up quickly when transferring large amounts of data.
• An OpEx model works best where there are peaks and valleys in spending for a program. Such peaks are often seen with up-front costs tied to new programs and initiatives. For example, both genomics and digital pathology may require high up-front costs for infrastructure and computation power, so a cloud-based OpEx model might be the best solution for newly transitioning organizations.

Best Practices on Defining Roles & Expectations during Cloud & SaaS Engagements

Attendees highlighted the high level of trust needed from both parties during SaaS engagements. Thus, up-front discussions need to be part of the contract negotiations, including details on what a prospective client needs and what each party is accountable for (regarding service resolution, upgrades, security, etc.). Provider organizations should have clear KPIs to help both parties come to an agreement. Best practices include the following:

Both IT vendors & healthcare organizations:

• Clarify expectations on what the vendor and provider organization will each be accountable for. The vendor needs to know how the solution will work, how to deliver it, and what performance a client can expect. The provider organization needs to understand the vendor’s offering, how it will work relative to existing workflows, how to best work with staff to drive adoption, and the expectations on acceptable performance levels for end users. Hyperscalers should be brought into the discussion to ensure SLAs around latency and performance can be achieved and determine what redundancy options are in place and how long potential downtimes could be.
• Give special attention to security. Healthcare organizations want vendors to shoulder more responsibility, as security resources are expensive and hard to retain.

Healthcare organizations:

• Understand the differences between an on-premises solution and a SaaS solution, which often allows for less customization but more regular updates. Transformation projects need leadership. Those involved in governance at a healthcare organization need to be flexible about configuration and personalization while also pushing for more standardization.
• Provide a lot of education to users about what is and is not in the cloud, especially as it relates to security. Clinicians’ priorities will be knowing how the cloud will impact them or the patient, including elements such as speed, efficiency, and workflows.

IT vendors:

• Seek to understand an organization’s challenges and strategic objectives and work together to ensure a successful implementation. Vendors shouldn’t start with a focus on selling; there should be an open dialogue about needed solutions, and vendors should be willing to say when they can’t provide something.
• Keep in contact with cloud providers (e.g., AWS, Google, Microsoft). Clients will expect communication between vendors and hyperscalers to be happening behind the scenes.

2023 Summit Attendees

Healthcare Organizations

Vendors/Consultants/Investors