– President and CEO Matthew Michela talk about how Life Image is creating easier access to breast imaging data while also solving some of data sharing’s biggest snags.
Interoperability—it’s the long-awaited result that evolving HIT promised to bring with it, and yet, it still gets left behind. Disparate data is not a problem exclusive to one data type or innovation; breast imaging, for example, has created some of the toughest challenges. However, there is now an app for that.
Life Image, which was founded in 2008, formed to overcome some of those interoperability challenges posed by the U.S. healthcare and evolving tech landscape. Since then, according to its President and CEO Matthew Michaela, the Newton, MA-based company has built a large global medical evidence network through a combination of technical expertise and unrelenting effort in the face of the many barriers that often stymie healthcare. Currently, the company connects 1,500 facilities with 150,000 U.S. providers and 58,000 global clinics, supporting more than 10 million clinical encounters per month.
“Medical data and in particular diagnostic images have traditionally been the toughest to access and transfer for all sorts of technical and administrative reasons,” said Michela. “Those barriers are compounded by misaligned business incentives between providers and manufacturers that keep data trapped in proprietary silos. […] In order for big biomedical data to enable efficiencies and accountability in healthcare, a high degree of interoperability is required to access disparate data sets and link data at an individual level.”
Michaela said Life Image is uniquely capable of providing medical data and network access using industry-based technology standards for a wide range of hospitals, physicians, patients, pharmaceuticals, medical devices and telehealth organizations, many of which utilize an even wider array of non-interoperable electronic health records (EHRs), picture archiving and communication systems (PACS), AI solutions, cloud environments and visualization analytics platforms.
Life Image’s latest app, Mammosphere, is just one of the many examples of how the company is achieving its long-term goals (the app free for the full month of October). HIT Consultant sat down with Michaela to learn more about the app and gain his perspective on the challenges and changes in the industry when it comes to achieving greater data access and interoperability.
HITC: Let’s talk about interoperability in healthcare for a moment: It has been one of healthcare’s most essential goals in the tech arena, and also one of its biggest challenges. As data mounts, tech silos continue to make processes inefficient and ineffective. However, there is also a consensus that the infrastructure for interoperability is coming together. What’s your perspective? Are apps the only way we can achieve this kind of interoperability since EHR technology hasn’t correctly supported that goal?
Matthew Michela: Well, we are indeed making progress, but we cannot rely on the large global healthcare diagnostic and technology companies to drive the pace of change. In order to truly solve the interoperability challenges in healthcare, you have to establish big broad networks of partners and end-users from everywhere in healthcare. This is different from the traditional model of the healthcare network, which is specifically designed to limit choices in order to drive volume and lower costs. That type of network keeps you confined within a defined geography, delivery system, referral circle or technology stack making it harder to access out-of-network services. Instead, the types of networks that move the ball forward in creating long-term value and innovation look more like cellular networks (such as Verizon or AT&T) that give you access to a broad and varied range of services and are simple to use.
For example, when you call or text someone, you do not have to think about whether your iPhone (or PACS for example) will connect to a Samsung phone (or EHR for example) on a different network. Likewise, you can use the network to access lots of different types of apps to watch movies, check your heart rate or post a picture to social media. These types of networks and the business models they create expand usage, increase access and force standardization of interfaces that facilitate innovation.
Life Image is deploying an infrastructure within healthcare that mirrors the consumer concept of high-performance data networks. Apps would serve a specific utility or function, such as collecting medical data and images from disparate places, or blood pressure from your phone, or measuring the air temperature in a long-term care facility from a thermostat. However, the network model is crucial to ensure access to this information with context to make it useful.
HITC: With Life Image, you are sharing breast imaging data. Talk to us about how the app works and how it addresses the specific challenges that come up with this exchange of data?
Matthew Michela: Mammosphere, part of Life Image, is a secure digital platform that empowers women with their medical history, with a focus on breast health. Mammosphere was founded to solve a pervasive problem in healthcare – the lack of interoperability that makes the sharing of medical data for women concerned about their breast health extremely challenging and stressful, particularly for complex diagnostic images.
Access to prior mammograms and breast health records are critical during a woman’s breast health journey, whether it is screening, diagnosis, treatment, remission, etc. However, breast health records are not easily or readily shared across systems.
Mammosphere is a simple-to-use, consumer-centric, Health Insurance Portability, and Accountability Act of 1996 (HIPAA) compliant application that eliminates the need for women to manually track down, pick up and transfer medical records. The diagnostic quality of mammograms and other images is retained. It eliminates the need for outdated, costly technology like CDs and processes like manually couriering records since all information is available and shareable through the platform. With a few clicks from a computer tablet or mobile device, a woman can gather and share her records on the go.
HITC: Do you think other app developers need to take a page out of your book when it comes to how you tackle interoperability and data sharing? What do developers need to do better when putting these products together?
Matthew Michela: Developers should spend their time and effort in creating solutions that are platform-agnostic and work seamlessly for broad populations. Every time a developer builds something with or to meet a proprietary standard, they reinforce the business models of narrow networks and create future technical debt for someone along the way.
HITC: On the flip side, what do you think healthcare organizations need to do to properly vet the technology they are using to exchange such important patient data?
I recently wrote an op-ed stating that everyone in the healthcare industry—regulators, vendors, providers, and patients—must tackle the thorny issue of corporate responsibility and transparency in managing the ever-growing volume of healthcare patient data.
The security and privacy of patient data have long been a concern and HIPAA has done a great deal to ensure it is not released or used inappropriately. However, HIPAA has also served as an easy pretext for refusing or slow-walking access to data that should be accessible by patients, clinicians and researchers for care coordination or to advance innovation. Beyond HIPAA-related issues, technology also gets blamed as a barrier for access. This has merit, but also reflects the lack of priority of organizations to address data availability. Additionally, the difficulty of properly de-identifying, or anonymizing, healthcare data has been a cost and timing concern.
So specific to your question, organizations have to make data sharing and interoperability a priority since it is arguably the most impactful advancement that can improve patient outcomes, provider and patient satisfaction, and lower costs across populations and our healthcare system. The crazy patchwork of data siloes is just that; crazy. Making data sharing and interoperability a priority means refusing to use solutions that create obstacles to data sharing. They may be beneficial in the short term but perpetuate a broken system. Additionally, they should demand their existing solutions to become more interoperable or be replaced.
HITC: Does the climate of tech-vulnerability factor into how you develop and continue to support your products? How real is the threat of data breach when we talk about patient data sharing in healthcare (including sharing with third-party apps), and how do you stay ahead of its increasing threat?
Matthew Michela: Safeguarding patient data is a 24/7, 365-day effort and is paramount in everything that we do: it is “Job One.” I do not want to reveal our approaches, strategies, methods or partners in getting this done for obvious reasons, but it is important to note that security absolutely influences what we develop, how we develop, how we operate, maintain and upgrade our solutions.
HITC: Imaging data is essential to patient-centered medical care and is also an essential component of the future of RWE (real-world evidence) programs. For example, there are data gaps in clinical trial designs due to the flaws in EHRs. How do you see companies such as Life Image being part of the solution of infusing clinical image data into RWE programs, and does that bring new challenges to successfully exchanging patient data?
Matthew Michela: For decades, biopharma has relied primarily upon structured data found in claims, pharmacy, lab and, more recently, EHR data to accomplish research goals. However, that data has clear elements of bias given it was largely created to facilitate medical payment or authorization for payment rather than clinical decision-making by providers. Even though these data types have limited clinical value, decades of standardization of claims systems, billing codes, lab systems, and pharmacy management platforms made this data available at scale. Therefore, the industry’s reliance on these types of data has been extensive. It is also becoming clear that the results of analyses based on these data types are not adequate for research today as biopharma solutions become more complex, more precise and targeted. As the types of available data explode, the ability to include other types of data in research grows. As computational power becomes more available, richer data and real-world evidence are seen as necessary to meaningfully demonstrate outcomes.
As a clear example, imaging in the form of DICOM pictures and radiology reports contain interpretations and other information and provide rich diagnostic and outcomes data but have historically been extremely difficult to access and aggregate at scale. Life Image, as the largest evidence-based network focused on multivariable medical data, has been solving for those technical challenges which is why we now are able to offer Real World Imaging™ (RWI), a solution set focused on curated imaging data for life sciences. RWI is dynamic data that has never before been available at scale for drug development and post-market initiatives.
HITC: With the above in mind, what do you think needs to change in the tech-develop environment to further encourage real interoperability in healthcare?
Matthew Michela: Full interoperability and the frictionless flow of clinical data are essential for patient safety and quality of patient care each and every day, and for innovation and advances in approaches to future patient care. Still, despite a variety of efforts over the decades, the otherwise technologically advanced U.S. healthcare system has made only sporadic and partial advances toward that goal.
The two issues of interoperability and data sharing somewhat overlap, with interoperability mostly referring to technical capabilities of software and systems to exchange and use data, while data sharing refers more to the business model, procedural or bureaucratic barriers to exchange data. This spectrum of barriers currently makes resolving the problem extraordinarily difficult, requiring partnership and collaboration. While the industry has made better progress to overcome the technical barriers, actions based on collaborative intent are still largely still missing.
The interoperability and data sharing provisions of the 21st Century Cures Act was intended to finally change this situation. Other areas of the economy, from transportation to manufacturing to going out for the evening, have been transformed by the free flow of data available through application programming interfaces (APIs). The Cures Act intends to create the same kind of information exchange through a range of incentives and fines for noncompliance. The Office of the National Coordinator (ONC) is tasked with the rulemaking around the interoperability provisions of the Cures Act, which it is advancing with its February 2019 release of proposed rules.
For interoperability, the ONC intends to create an environment that supports the development of an entire ecology of APIs. For example, innovative companies know that they cannot create a new environment of machine learning-based decision support enabled by APIs without appropriate access to de-identified clinical data to train those models.
The key directive in the ONC proposed rules is that clinical data should be shareable “without special effort.” These three words are essential for enabling the free exchange of healthcare data. The ONC believes this means the use of modern, industry-specific standards by all players. There are already many APIs, but their vendor specificity slows their uptake. It often takes many hours of customization for a user to get even a trickle of data, and smaller vendors do not have the resources to achieve even that.
HIPAA provides a workable foundation for data sharing, but the law has often been perversely interpreted over the years, typically to justify a refusal to share data. The Cures Act takes specific aim at data blocking, which is explicitly illegal. Rules are being created to define allowable exceptions, but the goal is to make these exceptions explicit and limited.
Most importantly, the Cures Act aims to eliminate the barriers patients currently face accessing their own medical records. Institutions often raise procedural and financial hurdles for patients, who end up suffering the most from the deficiencies in the current system of information exchange. Ultimately, it must be patients who control their own data, not clinicians or vendors.
While specifics are still being worked out, there will be clear consequences for failing to comply with the requirements for data sharing. EMR providers, health information exchanges and health information networks are the entities subject to civil and monetary penalties of up to $1 million “per event” enforced by the Office of the Inspector General.
Perverse incentives, status quo bias, and entrenched competitiveness have all contributed to a suboptimal system where information is too often inaccessible. The problems are varied. The change, it is argued, will be difficult, and no market participant will change unless there are clear positives and negative incentives, and coordination so that everyone moves forward together. Nevertheless, the benefits of the change far outweigh its difficulties.
