A South Carolina State-wide Database (RHIO + HIT) for near-real time analytics of anonymized health data from around the state
From pharma quality of product, pharma GxP auditing, healthcare ICD and notes patient data, and autopsy data; analytics suites,available to the public
The following is the outline for a bill that will be filed for the Spring 2024 session of the South Carolina legislature. It should have a high priority due to its high return on investment and low risk assuming rapid passage of the bill.
The Problem
Nationally and internationally, poll after poll shows a significant drop of confidence in science, healthcare, government management of healthcare, the media, and, specifically, the ability of all these organizations to manage and provide truthful information about Covid-19. In fact, I think it is worse than a “drop in confidence:” at all levels from WHO, to the US President, to the US Congress, to the US federal health organizations, such as the CDC and the FDA, to the pharmaceutical companies, to the national medical associations, to the state governors, to the state health organizations, to the healthcare systems in the states, to the national and local media, whether news organizations or social media- ALL have lost their integrity. Even worse, if this were a sane world, all would be criminally culpable for the death and harm they have inflicted on US society (and the nations of the world). To reestablish integrity, they should be held accountable for their crimes, all the way from malfeasance to crimes against humanity.
The lack of effectiveness and the safety of the Covid-19 shot is known. But data has been limited on the actual impact due to government control of those data, either directly or through conditions place on funding. There is an urgent need for a SCHIAS (South Carolina Health Information Analytics System). SCHIAS, which would be developed using the RHIO administrative model and the Health Information Technology (HIT) framework for technology, which includes architecture for health data, security, and management standards as understood in the medical database world. SCHIAS will remove our state’s dependency on the federal government and will fill the void in the ability to study vaccine safety issues, as well as any other health efficacy or safety issues associated with pharmaceuticals or treatment protocols that would potentially impact South Carolinians of all age groups and demographics.
In South Carolina there is a distinct widespread dissatisfaction with the handling of the COVID-19 response by our elected officials, state health agencies, and state healthcare facilities. Based on existing evidence there was a lack of communicating an objective disclosure of existing data and evidence about Covid-19 and Covid-19 public mitigation strategies including vaccination at all levels of government.
VAERS, the CDCs own reporting system for adverse effects shows there have been over 9,000 Covid-19 vaccine adverse events reported by South Carolinians of all ages. It is widely acknowledged that vaccine adverse events are significantly under reported. At the international level, the computed figure for serious adverse effects is about 7%, with the understanding that the serious adverse effects can be delayed; that damage can be for a life-time, with infertility and death a real possibility.
The state legislature, the executive branch, and, above all, DHEC are silent in saying, “this isn’t good enough for South Carolinians”. DHEC has repeatedly messaged that the Covid-19 vaccine is “safe and effective.” It does to this day even though it is clear that vaccinations are not “safe and effective.”
We now understand that the federal government does not endorse gold standard science when studying vaccines on the existing and future recommended vaccines we are being asked to accept. This reality means it not possible for citizens of SC, or even professionals, to transparently assess the safety profile of new and old vaccinations we are repeatedly asked to accept, further highlighting the need for the SCHIAS to be created in our state.
South Carolinians understandably will be questioning why our elected officials are not acting in our best interests to further investigate vaccine safety and are not passing legislation to protect medical choice and real informed consent that is in alignment medical ethics and actual science. State legislators allowing mandates of liability-free shots places the burden of risk squarely on South Carolinians instead of on pharmaceutical companies where it belongs. This is not good enough for South Carolinians.
Objectives
Re-establish integrity and trust in public health in South Carolina.
Remove the dependency on the federal government and transparently provide data and analysis support for pharmaceutical effectiveness and adverse effects which will support public health in South Carolina.
Establish a culture in the medical community that questions whether health problems are associated with pharmaceuticals as either unintended consequences or adverse effects which threatens public health. Provide funding to study and identify these threats.
Change state laws, as reflected in already submitted bills to the legislature, to protect the citizens from Constitutional overreach by the federal government and manipulation, incompetence, and poor policy recommendations regarding health and education by the executive branch of state government. Additional state initiatives are necessary to ensure that citizens of all ages can critically assess information in general, but especially information related to their own and their family’s health.
Change state laws, as reflected in already submitted bills, to protect SC citizens from Corporate and Institutional overreach, manipulation, incompetence, and poor policy recommendations regarding health.
Identify South Carolina office holders that do not support efforts to improve public health, to protect the informed consent ethic, or to protect human rights, and work to unseat them through the primary process.
Tasks
1. Write a SC Legislature bill to create and finance a RHIO. Pass the bill
2. Write SC Bills to establish the three dependencies for establishing integrity with respect to healthcare data analysis: (1) Insure quality of pharmaceutical products at the point of administration; remove products that do not meet standards (2) Audit the quality of supply chain, manufacturing, and logistics of pharmaceutical companies; ban products from those companies from sale in SC until Corrective Actions are taken and confirmed (3) Create an autopsy methodology for evaluating adverse effects and efficacy of suspect pharmaceuticals. A fourth dependency is to tie the databases that are associated with these effort together with the SCHIAS to provide meaningful and early warning analytics.
3. Educate and gain support of the Governor and Lt. Governor, requesting that one or the other publicly support and champion all the objectives of this roadmap. Educate the future candidates for the 2024 election on the bills and roadmap.
4. Establish a prototype for these four systems through an agreement with one or more regional healthcare systems that use EPIC. Establish a prototype for the computer system at Clemson. Use the prototype to bootstrap development to the point where operational specifications and requirements are documented. If possible, do this even before the legislative bills are passed.
5. Coordinate communication with interested parties, research, strategizing on how to accomplish objectives.
6. Pass the bills in the legislature.
7. Develop a multiphase project plan from the selection of a RHIO commission to availability of the final availability of the four databases for public analytical use. Through the prototype experience, establish workflows and plans to effectively use the data from the SCHIAS. We expect healthcare systems to have an interest in participating as they are an important stake holder in individual health and public health. This database should not significantly burden South Carolina healthcare systems. Protection of confidentiality/privacy of patient’s data is a priority and is part of a RHIO design.
8. Obtain support for the objectives of this roadmap from the new state health organization. Establish the process for root cause analysis and corrective actions based on the analytical results from the SCHIAS
Funding
1. Funding will be provided through the legislative bills.
2. Epic, through its representative, Jeremy Aikins (608.777.5620) says that any work needed to define the queries and to set them up would be supported by Epic as part of their ongoing contracts.
3. Deliverables before a final bill is written would include:
1. An RFI to potential service providers and response,
2. an RFQ to service providers and implementers and response, and
3. a full project plan and budget, with all operating protocols, including security design,
4. The budget would be presented to the legislature as a bill for development funding at the first session after initial funding for the prototype is available.
5. To avoid political influence and data corruption, there cannot be one dollar of funding from any source other than the state legislature.
6. The executive branch has control over the implementation and operation only in that the governor, in consultation with the Surgeon General, will recommend members of the RHIO steering committee, which will have executive responsibility over the entire project.
7. Once operational, the database (front end phara product quality control, through EMR records, through autopsy results) will be available for analysis by anyone, including DHEC and/or its successor. Nominal fees may be charged for data extraction and, if analytic services are desired, for analysis.
Dependencies
The bill should require all healthcare facilities that use EPIC to cooperate and provide SCHIAS with required data.
The author has already assembled a technical team to be principle investigators for this effort. It will involve international experts as well as MUSC, USC and Clemson faculty, analysts, and students.
Further Remarks on the SCHIAS RHIO
Benefits
The RHIO will be an essential state resource and service for the future, from Covid on, and for both infectious disease and other healthcare issues. The opportunities offered by the SCHIAS for thorough investigations of vaccine safety concerns and well-designed, planned, retrospective vaccine studies in South Carolina health care systems databases will lead to heightened interest by researchers, advocacy groups, members of the State Legislator, members of Congress, and others. The interest in the SCHIAS shown to date as it is presented has brought increasing attention that this database is urgently needed.
Requirements
The RHIO Board must be independent of all healthcare organizations. This means the voting members can not be or have been executives or employees of healthcare organizations or state government. All non-voting members will receive no compensation. The objective is to preserve the integrity of the Board.
Researchers, members of the State Legislature, managed care groups and the public will have the ability to have access to the SCHIAS.
The SCHIAS will provide deidentified data on patient characteristics, health outcomes (according to data resulting from inpatient, outpatient, and emergency- room records), and vaccination history (vaccine type, date of vaccination, manufacturer, lot number, and injection site). Researchers interested in particular vaccine safety hypotheses will have access and analyzing SCHIAS data
To enable studies on whether health problems are associated with vaccinations, the database includes data on vaccination histories, health outcomes, and characteristics of South Carolina patients in participating state healthcare systems. lic will have the ability to have access to the SCHIAS.
Five overarching principles became clear from the COVID-19 era related to the need for a SCHIAS are the following:
Independence. Ensure that potential biases and potential conflicts of interest are minimized, balanced, or otherwise managed in the design and implementation of all processes, practices, and policies related to the SCHIAS.
Transparency. Ensure that all processes, practices, and policies related to the SCHIAS are developed in the spirit of openness, clearly articulated, and easily available to interested persons or entities, and that any deviations from them are documented and justified.
Fairness. Ensure that all processes, practices, and policies related to the SCHIAS are designed and implemented in a fair manner.
Protection of confidentiality. Ensure that the design and implementation of the SCHIAS protect the confidentiality of individually identifiable information while enabling traceback to patients when adverse effects are detected that should be addressed by other patients that have the same medical situation
Timeliness. New snapshots of data should be available on approximately a weekly basis in order to capture early signals of adverse effects as well as new disease outbreaks.
South Carolina House and Senate Committees must be charged with, and held accountable for, oversight to ensure that the policies and procedures of the SCHIAS and its data sharing program are implemented as fairly and openly as possible.
Status
We have identified at least two premier principal investigators with both biological science and technological analytics background to anchor the professional team.
We have extensive project management experience- over 60 years- with projects like this and can deliver the funded project to the project manager on the RHIO team.
We have briefly looked at the Health Sciences SC organization,
with the hope that their database initiative could be extended to encompass this proposal. Unfortunately, we found:
1. The database is limited to a few hospitals.
2. The contents of the database are not known.
3. Access to the database is severely restricted to research institutions. It appears, due to the need for IRBs, that the resource is for those doing human experimental research, rather than analytics.
4. PHI data? The database we propose is like VAERS, but more timely and more current- near real time. It is also "raw." It has no PHI identifying information.[1]
5. One version of VAERS is accessible to anyone, including the new SC state health organization, as are country and regional databases around the world. As we have said, these are manipulated and inaccurate. Correspondingly, for healthcare quality, we would like as many people as possible to be able to run analytics on the data.
6. If some special form is necessary, then that can be accommodated, though I'm not sure what that form would contain.
7. The data in SCHIAS would be air gapped. No one can run a query directly. Queries would be defined via simulator available to the user. The actual query would be run by staff. The analytics would be defined by the user, though there would be a suite of analytic tools available with interfaces already built. The results would be returned to the user.
8. These data may or may not be used for human experimentation, just like VAERS. If there is a stipulation for IRB due to human experimentation, that could be set up.
9. The organizational setup for HSSC could be expected to result in bias and data control that would be unacceptable to a quality control and reporting system. The management of VAERS, as well as most other similar databases around the world, has proven that the temptation of managers to manipulate the data, removing those data that reflect poorly on the managers, is too great to resist. The data have become untrustworthy. The SCHIAS RHIO Board for our proposal can not include voting members that are associated with healthcare institutions or government organizations. There are probably other stipulations that would need to be made in order to retain the data's integrity, such as exclusion of certain university faculty. This is basically a data analytics function, and would best be served by experts in data analytics as a profession.
Proposed SCHIAS.
Title: A State-wide Reliable, Timely Database for Disease and Healthcare Protocol Analytics, Based on the RHIO Management and HIT Framework
WHEREAS: No specifications for quality control were contained in the development and manufacturing contracts for the Covid-19 mRNA “vaccines” and, to date, there is no evidence of adequate quality control. Evidence is available and documented in research papers of contamination and various parts and pieces of the primary components of the vaccine. There is no data on how this impacted South Carolinians.
WHEREAS: Both the federal and state governments used the psyOps weapon of FEAR to motivate force citizens to accept the “vaccine” without full informed consent. The federal and state governments, as well as the media, falsified data, manipulated hospital records, used funding to force encourage compliance, mismanaged and misapplied protocols, etc., emphasized cases rather than severe outcomes, used “fact checking” to provide misinformation, ALL to instill FEAR. We stipulate that this was morally reprehensible. DHEC “passed through”, apparently without critical review, the federal government’s faulty information. DHEC continues to report on their web page that the mRNA “vaccines” are “safe and effective.” Both are demonstrably untrue and legally open the state up to civil and perhaps criminal suits because those statements are misleading and negate “informed consent.” On the other hand, DHEC did not and does not have available accurate, dependable effectiveness and adverse effects data in order to provide accurate advice to the SC government and its citizens.
WHEREAS: All available AE data show the severe AEs are running somewhere between 7% and 15% of the population, but we do not have accurate data on SC. Through FOIAs, DHEC has admitted there is no system for tracking effectiveness and adverse effects of pharmaceuticals. For the Covid-19 era, the only real attempt at accurate data was to track shots in the arm. This is a faulty metric for pharmaceuticals and the responsibility for such metrics goes up to Governor McMaster. No doubt he was misinformed on the correct metrics for managing infectious disease, which then goes back to DHEC. The state does not have an effective and responsive methodology for tracking the effectiveness and adverse effects of a pharmaceuticals or, for that matter, treatment procedures. Neither does it have an effective earlier warning system and early treatment procedure methodology for future disease management.
BE IT RESOLVED: An independent organization be established that manages a new statewide database for anonymously tracking and analyzing patient data to faithfully and accurately measure effectiveness and safety. This organization, management methodology, and database system is an industry standard and is called a RHIO, or Regional Health Information Organization. The database would have a standard architecture based on the HIT framework.
Ref:
1. https://ohie.org/framework/
2. https://www.cms.gov/eHealth/downloads/Accelerating_HIE_Principles.pdf
3. https://digital.ahrq.gov/health-information-exchange-policy-issues
5. https://www.techtarget.com/searchhealthit/definition/Regional-Health-Information-Organization-RHIO (read the references at the end of the article too)
Background on FOIA responses from DHEC:
An Early Implementation, by Ross Lazarus, Harvard Pilgrim Health Care:
[1] Mechanisms exist in advanced database design that can be used to trace patient data back- in our case to an attending physician- without any person, even if they were able to hack the entire database, being able to decode the link. Our principal investigators have knowledge of these techniques. Physician data, as well as location and time data regarding events, will be masked by this technology.