Sarah Lichtner

Signed into law December 2016, the 21st Century Cures Act has allocated more than $6 billion over 9 years to accelerate medical product development and bring advances faster and more efficiently to patients who need them. At the end of November, U.S. Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released their initial vision for their Cures 2.0 legislation—building on the successes and progress of 21st Century Cures to date—along with a call for input from subject matter experts, patients and their families, and other stakeholders. The call for Cures 2.0 input outlines four focus areas:

  • Employing digital health technologies to transform access to medical services
  • Modernizing how new cures and medical products are covered financially
  • Harnessing data to empower patients and improve their health
  • Improving the ability of families and caregivers to support their loved ones

Nexight Group has identified three crosscutting areas of activity needed to advance the outlined Cures 2.0 focus areas. Our analysis is based on our strategic planning, technology roadmapping, facilitation and stakeholder engagement, and communications work in health and medicine, including our support to the U.S. Food and Drug Administration, Standards Coordinating Body for Regenerative Medicine, Kidney Health Initiative, Bill & Melinda Gates Foundation, National Cell Manufacturing Consortium and Cell Manufacturing Technologies Engineering Research Center, and Phil and Penny Knight Campus for Accelerating Scientific Impact. These considerations are also informed by our complementary expertise in advanced materials and manufacturing, cybersecurity, and infrastructure resilience.

The following activities are critical for Cures 2.0 to ensure the quality and safety of medical treatments, facilitate their affordability and access, and improve the quality of life of both patients and caregivers.

1) Establish Consistent Data Infrastructure, Management, and Security

Digital health technologies have significant potential to improve access to timely medical care, and data-driven methods for identifying and validating new medical products and treatments can help realize cures more quickly and efficiently. To harness the power of data and ensure its usability, the health and medicine community must:

  • Establish data infrastructure that ensures data consistency and quality: The value of data can only be unlocked if it is well-contextualized and trustworthy. Common methods and structures are needed for measuring, recording, organizing, and sharing data, as well as assessing its validity and accuracy.
  • Develop sources of real-world data: Companies must be incentivized to share data to build the comprehensive data sets needed to compare and validate technologies and treatments and to support regulatory decision-making and improved cost reimbursement models. A centralized convener could help anonymize data from private companies, minimizing individual company intellectual property risk while maximizing the body of knowledge available.
  • Leverage artificial intelligence, machine learning, big data informatics, and data visualization: These advanced analytical approaches can help make meaningful connections to efficiently improve treatments and products and develop personalized treatment plans that can yield optimal results. The health and medicine field can leverage best practices and lessons learned from other fields that employ data-driven materials discovery, but must also consider the added complexity of intrinsic variations in humans.
  • Reduce Cybersecurity Risks: Increased data sharing—both through digital health platforms and for technology advancement—increases cybersecurity risks. Cybersecurity safeguards will be critical to protecting personal patient information and company intellectual property and to ensuring security of smart medical devices. Such safeguards include consistently sharing and applying cyber hygiene best practices across the healthcare system (technology developers, clinicians, insurance, patients, etc.); employing tested platforms for data transfer; ensuring the integrity and accessibility of real-time data essential for patient care; and educating patients about how their data is shared, used, and protected.

2) Encourage and Assess Technology Development and Innovation

Whether in advanced medical products or the platforms needed to facilitate digital healthcare and harness the power of data, efficient and coordinated technology development requires a clear path and coordination across all relevant stakeholders. The health and medicine field must:

  • Engage diverse stakeholders—including technology developers, clinicians, regulators, and patients—to inform advances: Effective stakeholder engagement is critical to reduce siloed advances, share best practices and lessons learned, identify both challenges and opportunities, understand patient needs and preferences, and spur innovative thinking to uncover new solutions.
  • Advance standards that can improve product quality and accelerate innovation: Advancing standards in broadly applicable areas (e.g., data management and sharing, cybersecurity, technology interoperability, measurement and analysis) can encourage collaboration, facilitate innovative product development, accelerate regulatory reviews, reduce costs throughout the supply chain, and build public support for new medical products and treatments.
  • Continuously assess impact: The health and medicine field must define appropriate measures; regularly evaluate progress; and use data to inform decisions, drive change, convey value, and build and maintain external support. For example, the field needs to transform how it assesses the value of new life-changing treatments by considering long-term savings and improved quality of life over short-term costs.

3) Empower a Multidisciplinary Workforce

The field of health and medicine is changing rapidly, accelerating the development of new medical products and treatments and transforming the way healthcare is delivered. Capitalizing on this momentum demands a highly skilled workforce with multidisciplinary skills, including in biological science, medicine, engineering, computational modeling, physics, chemistry, mathematics, data science, quality assurance, standards and regulatory frameworks, and business. To equip the workforce with these skills, the health and medicine field must:

  • Link industry and academia to align training programs with needs: Deliberate and purposeful collaboration between these two stakeholder groups is critical to ensure that training programs focus on building the skills that industry needs most.
  • Expand access to multidisciplinary training programs: Current training in health- and medicine‑related disciplines must be expanded or supplemented to produce workers who not only can implement advanced technologies and practices but also recognize opportunities for continued innovation.
  • Enhance training in data management and cybersecurity: Cybersecurity depends on prevention and response; workers must know how to support both. To do so, all levels of the existing and next‑generation workforce must be trained to protect intellectual property, patient data, and network systems.

Please contact us at Nexight Group to learn more about our support to the health and medicine field and our services: