CONTACT:
- John Norris
- 617-680-3127
- John.Norris@Safely2Prosperity.com
- https://www.safely2prosperity.com
February 3, 2024 – (BOSTON)
I am a former FDA COO and Harvard faculty member, and a decades-long infectious disease spread risk management expert. (It’s the rate, depth, and breadth of “spread” that most counts.) At the FDA, I co-led its last major internal reform. At Harvard, I taught policy, law, and management, including risk management.
A few days ago, at the World Economic Forum in Davos, Switzerland, the top executive of the World Health Organization called for immediate preparation—through the creation of nation state-level and enterprise-level “systems of systems” to promote, require, and begin to regulate “preparedness”— for worldwide risk management of infectious “Disease X” spread. Disease X is the next far more significant outbreak than the COVID-19 Pandemic waiting just around the corner.
Government agencies and businesses (for-profit and not-for-profit) worldwide were caught off guard when COVID-19 struck full force in 2020. WHO demands proper preplanning for the hypothetical more dangerous Disease X—a pathogen projected to be responsible for
creating a next-generation pandemic that is much larger than the COVID-19 Pandemic, perhaps one that kills as many as 50 million people (or more) worldwide, many of the avoidably, if we are not prepared, and directly wastes many 10s of trillions of dollars worldwide.
Most government agencies and businesses were totally or substantially unprepared in 2020 for a pandemic-sized attack by a dangerous pathogen—one that was both very dangerous and harmful in terms of being deadly or seriously and sometimes permanently debilitating.
And one that was highly spreadable because, given our “shrunken globe,” a person can travel by jetliner to the world’s farthest reaches in 24 hours. Compare that to the spread of the deadly bubonic plague (the “Black Death”) when it took years by camel or boat in the Middle Ages to kill an estimated half the population of the world.
The Director-General of WHO announced his critical concern about the almost instantaneous worldwide spread of “Disease X,” a far more dangerous pathogen, whether nature-made or human manufactured, than COVID-19. He emphasized that, in his opinion, it is “when, not if,” the nation-states and enterprises of the world will be confronted with the spread of this far more dangerous pathogen.
He calls for both public and private oversight. For now, I prefer and recommend primarily private oversight. I take this position once again to prevent the destruction of innovation in this category and the slowing of the pace of innovation. Intuitively, in the late 80s, then FDA Commissioner Dr. Frank Young, with the strong support of his staff and FDA’s career employees, created a decades-long path for developing most of the miracle healthcare IT “devices” we rely so heavily on today.
Without that insight and leadership by Dr. Young, this, at the time, fledgling industry would have been significantly stifled for decades, and, likely, many of these life-saving innovations we depend on today would not yet exist. This differs from saying that public agencies like the FDA don’t need proper oversight roles. But the oversight should continue to be milder and far less financially expensive, both to the agency and to the device developer, than the oversight now applied to drugs.
This is possible since embedded enterprise-based patient and staff
safety programs, such as those at the Massachusetts General Hospital, enterprise-oversight-based voluntary private organization programs, such as those at The Joint Commission, and dedicated robust digital tools, such as those invented and developed by Safely2Prosperity, now exist. Together, they provide a significant level of private oversight and highly functional and configurable support when providing oversight and preparation at the enterprise level.
Plus, appropriately, the FDA does not regulate health and healthcare “delivery systems,” such as hospital-led or other groups, hospitals, clinics, nursing homes, and assisted living facilities, or their “application” (use) of drugs or medical devices, including their healthcare IT or derivative products.
That role has been fully and appropriately allocated to The Joint Commission—which provides oversight and mild, yet appropriate, direct private de facto “regulation” to 22,000 healthcare organizations in the US—and, by influence, many others worldwide.
S2P’s enterprise-level (and later, through adaptation, further innovation, and refinement, nation-state-level) system of systems digital platform (including machine learning and later AI-driven) oversight, when paired with sophisticated accounting and analysis of the continuously validated and authenticated preparation for and timely, efficient, and effective execution of needed, decisive preemptive or responsive actions to prevent, mitigate, and control the spread of such a dangerous (deadly plus highly spreadable) pathogen.
It is “transformative.” It is essential and innovative. It throws out much of the now threadbare, non-disease-free sanctuary (haven) rug woven for risk-managing pathogen spread during the 1918 Flu Pandemic—the predominant approach still used for COVID-19 Pandemic risk management. It takes the opposite approach used for COVID-19, closing businesses and schools, which did far more damage than good. It keeps the workspaces safe for employees— and the companies uninterrupted and productive.
This critical comprehensive prevention, mitigation, and control of spread is accomplished using advanced assessments of employee and family
protection needs and costs—and by tracking appropriate administration of employer-selected “best-of-breed” vaccinations, tests, therapeutics, and other health and healthcare services and products.
The system of systems at the enterprise-level risk manages the quality, cost, nature, and timing of interventions in conformance with rules set by employers in a highly configurable digital environment. Among other things, it uses sophisticated and precise 24/7/365 continuous oversight and assessments that automatically create advanced analyses, reports, alarms, alerts, and other essential actions to develop and maintain high levels of facility safety. So, by adding employer-determined rules for exposure tracking, lengths of isolation of sick and quarantine of exposed employees, and other risk-management-related measures, in combination with powerful electronic-computing tools, it gets the job done.
This enterprise-level system of systems will “systemically revolutionize” the risk management of infectious disease spread within enterprises, such as inside government and business facilities, to prevent, mitigate, and control the spread by and among employees and the employees’ spread to or from their homes.
I mostly agree with WHO’s Director-General. My refinement: Supportive, largely private “regulation” of America’s many fragmented health and healthcare components using systems of systems is the intelligent thing to do.
It is the best way to ensure each country’s Disease X pandemic preparedness at the nation-state and enterprise levels is sufficient to protect each of the discrete parts and all those they serve. Taking this approach will make a critical difference in America’s and its enterprises’ ability to not just survive but thrive during the next pandemic, whether nature-made or human-manufactured. There is always a next pandemic.
By these advanced means and ways, the health of employers, investors (taxpayer or funder), customers and suppliers, employees (and their jobs), and families are significantly protected.
My teammates and I have invented and developed a significant digital tool that provides part of the solution. It is the best in the world. But
everyone must now kick in. You can text me at 617-680-3127 to learn more—and to explore how S2P’s VirusVigilant digital platform can help protect your enterprise and its employees.
© 2024 Safely2Prosperity LLC and Dr. John Norris. All Rights Reserved.
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