Posted: 19 Jul. 2019 4 min. read

Catalysts for change: Meet the life sciences regulator of the future

By Kevin Brault, Federal Health Care Sector leader, Deloitte & Touche LLP

As technology continues to drive the health sector further ahead, regulators—particularly in life sciences—might need to become more agile so they can foster innovation while continuing to ensure product effectiveness and consumer safety. Regulatory bodies have historically issued rules and required industries to abide by them. But the future of health is being largely dictated by software. Software is used to create drugs, build medical devices, and enable virtual care. Software, in the form of machine-learning algorithms, is also showing promise in its ability to diagnose disease. Given that software is typically in a constant state of change, it can be difficult to regulate using traditional strategies.

Consider this: In the late 1800s, so-called red-flag regulations in the US and United Kingdom were developed to protect pedestrians, livestock, and horse-drawn carriages from a new innovation—the automobile. One rule for early automobiles required three operators inside the vehicle and a fourth person to walk in front of it (waving a red flag) as it sputtered along.1 Such regulations likely did little to protect the public and might have hindered advances in the development of automobiles.2 Regulators of the future should balance their historic role of protecting citizens with their ability to advance innovation in new technologies and businesses.

Are regulators becoming more enlightened?

In a paper published last year, my colleague Bill Eggers explored the principals for regulating emerging technologies. He explained that regulatory leaders are faced with a key challenge: How do you protect citizens, ensure fair markets, and enforce regulations while allowing new technologies and businesses to flourish?

Emerging technologies such as artificial intelligence (AI), machine learning, big data analytics, distributed ledger technology, and the Internet of Things (IoT) are creating new ways for health stakeholders and consumers to interact. They are also often disrupting traditional business models. Fortunately, there are regulators who understand the importance of keeping the doors of innovation open while also ensuring the effectiveness and safety of products through regulation. The regulator of the future should move from a process-based, rules-driven approach to an outcomes-based, framework-driven approach. While these regulators should continue to focus on consumer protections and patient safety, they are positioned to become catalysts for innovation…in addition to remaining stewards of regulation.

Pre-Cert program points to the future of health

Software that can perform complex medical functions, diagnose medical conditions, suggest treatments, or inform clinical management is known as software as a medical device (SaMD). This technology can help patients play a more active role in their own health, but it can’t be regulated in the same way as traditional medical devices or pharmaceuticals. A pill or a stent, for example, doesn’t change once it enters the market. This is not the case with SaMD. Software might undergo constant updates or improvements after being released. During an interview last year, Bakul Patel, director of the US Food and Drug Administration’s (FDA) digital health division, acknowledged that the agency’s existing regulatory approach won’t be effective as the health sector becomes more digital.3 Digital health products do not behave like industrialized products—they are typically designed for constant change.

In 2017, recognizing SaMD as a potential growth area, FDA launched a software precertification (Pre-Cert) pilot program with nine companies. The Pre-Cert program, which is intended to enable faster SaMD approvals, was inspired by the Transportation Security Administration’s (TSA) PreCheck initiative—a trusted-traveler program designed to expedite security screening at airports. Similarly, the Pre-Cert program is a risk-based, expedited, and predictable approval process for organizations that demonstrate a commitment to a culture of quality and organizational excellence (CQOE). This might be the best example of a regulatory body that has reimagined how regulatory science can ensure that digital products are safe and effective for consumers.

The Pre-Cert program recognizes that digital health technologies can be developed much more quickly than more traditional health products. They can change rapidly while on the market—from AI or machine-learning algorithms. This understanding can encourage innovation to take place more quickly while also ensuring effectiveness and safety. The intent of the program is to provide more streamlined and efficient regulatory oversight—helping products reach the market safely and operate effectively while not inhibiting time-to-market speed and innovation in the pre- and post-market stages.

Health regulators are often viewed as governmental traffic cops that make sure industry follows the rules. As the future of health unfolds, regulators will play an essential function by setting the standards for how business is transacted. I expect regulators will play a bigger role helping influence policy to drive innovation while promoting consumer and public safety.

For industry stakeholders, this might feel like something completely new, but I see it more as a reapplication of an old mandate for a new world.

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Kevin Brault

Kevin Brault

Principal | Deloitte & Touche LLP

Kevin is a principal with Deloitte & Touche LLP and is the Federal Health Care sector leader, responsible for managing, implementing, and operating all aspects of sales and delivery across the Federal Health Care sector. Kevin has more than 20 years of federal experience in the design, architecture, development, and integration of information systems, risk management, financial controls, security audits, and cyber risk programs. Previously, Kevin served as the Federal Advisory Market Offering leader and lead partner for Health and Human Services. He has led work across multiple clients including: Health and Human Services, Department of Defense, Department of Commerce, and General Services Administration. Kevin serves as an officer of the Board of Directors for a non-profit organization named Empowering Action focusing on serving the desperately poor in their local communities in third-world countries.