Business Talk Magazine

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.