The Life Sciences industry has experienced significant growth in recent years, with advancements in medical technology and an increased focus on healthcare innovation. This growth has had a profound impact on compliance within the industry. As new drugs, therapies, and medical devices are developed, regulatory agencies have placed greater emphasis on ensuring that companies adhere to strict quality standards and safety regulations. This has led to an increased need for real-time compliance solutions that can effectively monitor and track adherence to these regulations. With the ever-evolving landscape of the Life Sciences industry, compliance requirements are constantly changing. Companies must stay up-to-date with new regulations and guidelines to ensure that they remain compliant at all times.
In this interview with TechBullion, Timothy Nobles, General Manager at Integral shares with us how real-time compliance company Integral supports healthcare businesses in their effort to proactively identify areas of non-compliance and take corrective action before issues escalate, among other opportunities available at Integral.
Please tell us more about yourself.
I’m Timothy Nobles, and I serve as the General Manager at Integral.
Over the past two decades, I’ve been deep into data and analytics, working in early and growth-stage companies across OEM automotive, FinTech, and Healthcare. Prior to joining Integral, I was the Chief Product Officer at Trilliant Health, where we focused on expansive predictive analytics for the health economy. Then, I was the Head of Product at Embold Health, where we aimed to offer objective Provider quality measurements to aid self-insured employers in guiding their employees towards providers that offer the right balance of cost and quality based on their specific care needs.
Integral recently secured a $6.9 million seed round; tell us more about your solutions at Integral and what you will do with this funding.
Integral’s privacy-enhancing platform enables healthcare businesses to work with highly sensitive and regulated data, akin to how major consumer brands operate, while staying compliant with regulatory requirements. Our Privacy Engine introduces a defining level of transparency for evaluating risks embedded within data. Our Privacy Engine makes it more straightforward and faster than ever for companies dealing with sensitive data to optimize datasets for both compliance and fidelity.
We are grateful to our investors. This funding will bolster our growth, enhance product development, expand our team, and ensure scalability. Our platform already delivers significant value to our customers. However, we want to provide even more capabilities for privacy simulation and data management. Advancing our roadmap will unlock even greater potential.
How does Integral help life sciences companies accelerate their data processing?
Our platform rapidly identifies where HIPAA risks lie within datasets. We can process an extensive dataset and reveal fields that are more nuanced than the standard PHI fields. This gives our customers options when crafting datasets that are de-identified and optimized for the highest data fidelity. This process, which used to take weeks or months, is now completed in just days, a speed made possible only after Integral’s launch.
In addition to the primary determination mentioned above, this speed greatly benefits our customers in several ways. I would highlight two; 1) the platform helps keep tabs on recertifying expiring determinations, and 2) as opportunities arise to combine new datasets, our platform can run in near real-time, supporting evaluation and determination needs at the pace of commercial deal-making.
What measures does Integral take to ensure secure collaboration when working with sensitive data?
Ensuring compliant and secure collaboration is at the core of everything we do. Our goal is to function as part of a company’s defense-in-depth strategy. To do this, we approach secure collaboration from multiple angles.
Ensuring compliant and secure collaboration is what we do. Our primary objective is to integrate seamlessly into a company’s ‘defense in depth’ strategy.
Our HIPAA-compliant platform offers a centralized, neutral area where all documents, attestations, data dictionaries, datasets, and stakeholders can engage securely.
Using the Privacy Engine, we discern the inherent risks in the dataset(s).
When fitting, we construct synthetic datasets from the given data dictionaries, which act as an added abstraction layer for assessment. This method allows our customers to examine the (synthetic) data securely.
When holding customer data during the Expert Determination process, unless specified by the client, we ensure its destruction is in line with NIST standards.
Can you provide examples of the novel insights that can be discovered by leveraging de-identified data?
There are so many!
Right off the top of my head, I think about Oncology. Oncology therapies are becoming increasingly unique and individualized. Aggregating those unique insights for care delivery communities and the market as a whole, in a de-identified, privacy-enhanced way could materially change and accelerate how we distribute learnings about oncology treatments.
By combining data in privacy-enhanced ways, health systems can get rather granular on how Social Determinants of Health (SDoH) are directly influencing the delivery of care in the communities they serve. Such data could support care delivery providers rethinking their approach to care access, the types of services they offer, and how they can more deeply participate in the communities they serve.
In terms of machine learning – data science work and model development – we’re starting to see a greater ability to develop predictive models regarding therapeutics, care consumption patterns, payer plan design, and more.
Why is it important for companies in compliance, life sciences, and data processing to work with expert certifications when handling de-identified data?
The Regulations suggest the need for an objective third party to confirm that the data are certified as compliant with the Safe Harbor or Expert Determination frameworks. This doesn’t prevent companies from hiring counsel, bringing in statisticians and running the processes in-house. Still, I like to compare the determination process to doing your own taxes vs. hiring a CPA. Hiring an expert shields you from risk and redistributes liability. With Integral, companies can better realize the fullest potential of the data while keeping it safe and compliant. Our platform is expressly developed to achieve this quickly.
How does Integral help compliance teams?
We give compliance teams the confidence to be comfortable supporting business requests related to sensitive data. CISOs, Privacy teams, and counsel genuinely work to keep the businesses and staff they serve safe. This often means they end up taking a conservative approach because it’s too hard to cover every risk vector – especially when humans are involved. They introduce policies designed to prevent risk and err on the side of caution. They say no a lot because that is what’s required to keep the business safe.
Every day, we see strategy, product, marketing and sales teams wanting to use data or asking for analytic insights that directly oppose these risk-prevention policies. Compliance teams experience tremendous overhead when making judgment calls on whether or not to support these requests.
Integral provides rigor, objectivity, transparency, and reliability to compliance teams. Making changes and refreshing data within our platform is quick, where any change to a dataset is recorded and recertified, as required. These controls give compliance and security teams the comfort and confidence to afford teams more flexibility and imagination in maximizing sensitive data.
Can you explain how collaborating with de-identified data can lead to innovative business decisions in the life sciences industry?
For example, collaboration of shared information from clinical trials has many benefits, such as sharing the efficacy of treatment protocols via de-identified data to look at precursors and identifying geographic areas where a need might exist for a particular therapeutic. There are also opportunities to train doctors as life science companies uncover significant treatment opportunities from their research. Academic centers can benefit when de-identified data is more readily available without extensive legal agreements and highly sensitive data flying back and forth. New research can spring from academia working in a reciprocal nature with life sciences groups to use data that originated from a life sciences company.
Consider the collaboration around shared information from clinical trials; it presents numerous benefits. Sharing the efficacy of treatment protocols via de-identified data can uncover precursors and identify regions with specific therapeutic needs. Moreover, medical professionals can receive better training as life science companies unearth pivotal treatment opportunities from their research. Academic centers stand to gain immensely when de-identified data is accessible without exhaustive legal barriers and the potential risks of transferring highly sensitive data. De-identified can be part of what paves the way for groundbreaking research.
How will Integral’s technology impact compliance roles?
Simply put, Integral is the platform compliance, data analytics, and product teams have wanted for a while. Integral is designed to make functions across roles more collaborative, faster, and easier. We consistently see where the platform increases their comfort and confidence when sensitive data is in play.
How can people connect with Integral?
We’re always ready to speak with investors, new businesses, and potential clients. It is a delight to have conversations with people interested in being a part of our growth story. We encourage people to visit our website, useintegral.com or email us, firstname.lastname@example.org
Integral, with its privacy-enhancing platform, stands as a pivotal player in supporting healthcare businesses in their quest for proactive compliance. Timothy discussed how the recent $6.9 million seed round funding will further fuel Integral’s growth, product development, and scalability, unlocking even more potential in the privacy simulation and data management space. The interview provided an in-depth understanding of how Integral accelerates data processing, facilitates secure collaboration with sensitive data, and the novel insights that can be derived from de-identified data. As he pointed out, among other things, this innovative approach to data handling and privacy-enhanced collaboration can lead to transformative business decisions in the life sciences industry.