USA EQUITIES CORP. (OTCMKTS:USAQ) Files An 8-K Entry into a Material Definitive Agreement

ME Staff 8-k
-
0
USA EQUITIES CORP. (OTCMKTS:USAQ) Files An 8-K Entry into a Material Definitive Agreement

USA EQUITIES CORP. (OTCMKTS:USAQ) Files An 8-K Entry into a Material Definitive Agreement
ITEM 1.01 ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT

The information contained in Items 2.01 and 5.06 below relating to the various agreements described therein is incorporated herein by reference.

ITEM 2.01 COMPLETION OF ACQUISTION OR DISPOSITION OF ASSETS

On December 20, 2019 USA Equities Corp entered into and consummated a share exchange with the former stockholders of MPI to a share exchange agreement (the “Exchange Agreement”) by which we issued 2,172,600 shares of our common stock, $.0001 par value (the “common stock”) to the former stockholders of MPI in exchange for all of the then issued and outstanding shares of common stock of MPI (the “Share Exchange”). MPI, based in West Palm Beach, Florida, is focused on value-based healthcare, informatics and algorithmic personalized medicine including digital therapeutics, behavior based remote patient monitoring, chronic care and preventive medicine. As a result of the Share Exchange, MPI became our wholly-owned-subsidiary.

Prior to the Share Exchange, Troy Grogan, was the President and Chief Executive Officer of MPI, and the holder of a majority of its outstanding voting common shares of MPI. Mr. Grogan is our Chief Executive Officer and a Member of our Board of Directors and the owner of a majority of the outstanding shares of our common stock after giving effect to the Share Exchange.

The foregoing description of the Exchange Agreement does not purport to be complete and is qualified in its entirety by reference to the copy of the Exchange Agreement included as Exhibit 2.1 to this Current Report on Form 8-K which is incorporated herein by reference.

The Share Exchange is intended to constitute a tax-free reorganization within the meaning of the Internal Revenue Code of 1986. Following the Share Exchange, we continue to be a “smaller reporting company,” as defined in Item 10(f)(1) of Regulation S-K, as promulgated by the SEC.

For accounting purposes, the acquisition of MPI by us through the consummation of the Share Exchange has been accounted for as a reverse acquisition under the purchase method for business combinations, and accordingly the acquisition has been treated as a recapitalization of USA Equities Corp. with MPI as the accounting acquirer. Consequently, the historical financial statements of MPI are now our historical financial statements. The financial statements of MPI are set forth in Item 9.01 (a) of this report. For pro forma financial information see Item 9.01 (b) of this report. Effective March 1, 2019 (“Inception”), the MPI’s sole director contributed services and paid expenses previously incurred in anticipation of the formation of MPI. Accordingly, the balance sheets and related statements of operations, stockholders’ equity and cash flows reflect activity prior to the MPI’s date of incorporation.

Immediately prior to the Share Exchange, we were a publicly reporting “shell company,” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Accordingly, set forth below is the information that would be required if we were filing a general form for registration of securities on Form 10 under the Exchange Act for our common stock, which is the only class of our securities subject to the reporting requirements of the Exchange Act upon consummation of the Share Exchange.

FORM 10 INFORMATIION

Summary

Medical Practice Income, Inc. (“MPI) was incorporated in Florida on February 25, 2019. MPI is focused on value-based healthcare, informatics and algorithmic personalized medicine including digital therapeutics, behavior based remote patient monitoring, chronic care and preventive medicine. Our intellectual properties, products and information service development portfolio are directed towards prevention, early detection, management and reversal of cardiometabolic diseases. Our principle objectives are to develop proprietary software tools and approaches, providing more granular, timely and specific clinical decision-making information for practicing physicians and other health care providers to address today’s now younger, obese, diabetic and cardiovascular disease population.

We are in the process of developing a high-level, fully automated cloud-based Software as a Medical Service (SaaMS) system named the Quality Health Score Lab Expert System (“QHSLab”) which will provide physicians and other healthcare organizations with an advanced platform to securely capture and store patient information electronically in a secure database. The patients’ data is intelligently filtered, analyzed and processed according to specific and proprietary algorithms. To date, we have completed the initial design of QHSLab and developed our initial Quality Management System. Our focus for the immediate future, assuming we can obtain sufficient financing is to develop and complete testing of our cloud-based system engineering in the first quarter of 2020 and launch our Minimum Variable Product in the second quarter of 2020.

Industry

The healthcare industry has yet to experience the improvements in outcomes, access, and cost-effectiveness that have transformed many other industries through the use of digital technologies. In an effort to address a worsening pandemic of chronic disease, technology companies are now contributing innovative solutions that enhance chronic care management through remote monitoring digital applications to reduce the burden of care on healthcare systems.

The term “digital health” describes technologies that engage patients for health-related purposes; it encompasses a wide range of products referred to as e-health, mobile health, or mhealth, digital medicine, digital therapeutics, or digital wellness often all interchangeably and used across the wellness and healthcare industries. Digital health is broadly used and misinterpreted to the point that it has no real meaning, especially to prescribing physicians and other healthcare providers.

The medical and scientific community prefers the term “digital medicine” as opposed to digital health to differentiate other more consumer orientated labeling of digital products that have not been rigorously tested for outcomes. Digital medicine is a term used to describe evidence based digital products that measure an intervention, including those intended for health promotion and disease prevention. Digital medicine differs from ‘digital wellness’ which is associated with such measures as Fitbit, sleep scores and Apple watch apps for example. Wellness products are not subject to testing and intended to be consumer-facing rather than used in clinical care. Digital wellness applications often lack evidence necessary to support medical claims for the information they produce.

Digital medicine products are driven by high-quality hardware and software that support health research and the practice of medicine broadly, including treatment, recovery, disease prevention, and health promotion for individuals and across populations. Whereas traditional health measures represent a snapshot in time – a lab result, a diagnostics image, a blood pressure reading or a note in a medical record – connected digital medicine applications and devices can offer longitudinal and highly personalized windows into personalized human health.

Digital medicine products can be used independently or in concert with pharmaceuticals, biologics, devices, or other products to optimize patient care and health outcomes. A key component of digital medicine is the transformation of raw physiological and environmental signals or active patient responses to surveys into health indicators that can be used to monitor and predict aspects of health and disease. This data is processed, transformed and used to build computational models whose output represents the health indicators of interest. Digital medicine empowers patients and healthcare providers with intelligent and accessible tools to address a wide range of conditions through high quality, safe, and effective measurements and data-driven interventions.

Digital Therapeutics, a derivative of digital medicine, extend physicians’ reach by overcoming time, place and personnel constraints that limit health-care delivery, creating better access, convenience and efficiency. As well as being considered treatments in their own right, digital therapeutics are proving useful in helping people to gain the maximum benefit from conventional pharmaceutical therapies. Provisions in the Affordable Care Act are making healthcare provider reimbursements dependent on outcomes and data capture, giving health-care providers an economic incentive to tackle patient adherence to prescriptions with fewer unnecessary medical interventions, all with the aim of taking better care, delivering better quality of life, producing better outcomes with fewer resources and lowering overall costs to the health care system.

Overview of Planned Development of the QHSLab Expert System

 

Our QHSLab Expert System will be capable of handling large quantities of data, without compromising accuracy or precision. It will not require expensive human resources to perform low-level mundane tasks. We can set parameters to accommodate prospective client physician and healthcare organization policy and will deal easily with significant increases in potential user work load. Our cloud-based software and IT system currently under development will easily scale to allow a virtually unlimited number of user sessions to be activated, all of which ultimately tap into the same software and database. The QHSLab approach to user capacity will be able, with certainty by utilizing a set, well-known path built into our third-party ‘robust’ cloud server infrastructure, to not only scale to a large number of users, but it will also be built on a globally-scalable architecture, allowing us to deliver high availability to users in just about any geographic region.

The importance of identifying health risks and the indicators to be identified varies within different healthcare settings and sectors. Some healthcare settings require psychological data while others require a detailed medical history and list of medications. Certain industries have increased occupational risk factors and health surveillance profiling must be specifically tailored for that industry. To address these unique needs, our QHS Lab utilizes three primary areas: assessment, scoring and feedback.

Assessment

 

Assessment collects behaviors of interest, health and medical data, and psychosocial variables considered important determinants of disease risk and behavioral change. The Questionnaire and Survey Creator is a generic tool that allows the clinical user of QHSLab to build specific ‘dynamic forms’ for medical and health assessments that allow for variations within the setting or industry that ultimately do not harm the integrity of the overall collection of research-based health data for wider analysis. The generic form creator allows QHSLab to build data sets tailored to specific user-groups, users and customer requirements. These settings allow for specificity when benchmarking populations and organizations within industries.

Scoring

 

Scoring is guided by computer-based decision rules, also known as Artificial Intelligence or AI, using pre-programmed mathematical algorithms. For example, the Quality Health Score™ (QHS) Algorithm makes use of an individual’s accumulated health risk data over time and pin points necessary changes to lower health risk based on behavioral and psychological principles, which programmatically guide the individual to lower his health risk. The QHS algorithm adapts to the individual’s changes and resets goals and plan of direction, through ‘Machine Learning’ and ‘Big Data Analytics’ methodologies.

Feedback

 

Feedback provides individually-tailored reports. Our QHSLab Feedback Reports utilize incoming responses from assessments, the calculations from scoring algorithms and combines key words, sentences and paragraphs in a manner most likely to effect behavioral change beneficial to the user. The underlying constructs that guide the expert system stem from behavioral theory and computerized AI. QHSLab provides normative (compared with population norms) and ipsative (compared with previous scores) feedback on salient variables relevant to the general population and the specific individual being served.

Advantages of the QHSLab Expert System

QHSLab has the potential to play the same role in behavioral medicine and life>

Through purposeful design, the QHSLab Expert System aims to:

QHSLab will also incorporate a wide variety of different intervention materials. Our AI driven approaches will range from motivational materials for participants in early stages to detailed advice and support for participants in later stages of behavioral change. As a participant progresses (or regresses), different intervention materials will be available.

Our system will provide an automated recording device so that minimal amounts of progress can be detected and reinforced. Gathering data through automation provides an extensive empirical data base that can be used to both serve the participant and provide an evaluation of the effectiveness of the system. Since health risk prevention can be very expensive in terms of the resources required to provide services to all participants, QHSLab represents a far less costly alternative.

Components of the QHSLab Expert System

Our QHSLab will include a Global Data Definition (GDD) function which will conform the meaning of data across ubiquitous parameter sets in a way that will enable QHSLab to cross correlate data without manual intervention. Data may be collected through different platform domains, collection techniques and services. For example, patients may enter their weight using a home scale or a healthcare professional may weigh the patient and enter the data. Alternatively, scales with a Bluetooth connection can send the data electronically to the database. All will be read and incorporated into the patients’ profiles. The GDD table allows the user to track variables between data sets and gives them the required functionality to modify data reports for analytical and research purposes.

The Queryable Dataset Tool (QDT) will utilize the industry leader ‘Elastic Search’ platform to ensure that our customers have access to their data at any moment. Reports are generally executed via technical templates, hard coded by skilled IT labor and impractical for a layperson to use. This approach to retrieving data can be quite time and cost intensive. The QDT tool will allow authorized QHSLab personnel the ease to select and format data whenever needed. The QDT makes use of defined parameters that are aligned by the GDD. It introduces a technical layer of efficiency when performing the queries. The result is a fast, accurate and efficient system that a non-IT individual can use to create professionally tailored reports and templates with confidence.

The QHSLab information management system will collect, store, analyze and report all elements, components and relationships of the business at a high level to provide transparent and accurate information on which decisions and policies can be based. A key feature of the system is the System Manager.

This System Manager is purposely built and yet comfortably generic. It houses specifically-designed data capture software and modules engineered for ease of use and the minimization of data entry errors. The System Manager allows for version specific dashboards, allowing clients, customers and users a way to enter, report, compare and readily access data.

Key features of the QHSLab System Manager under development include:

● Super administrative ability to create new user accounts, user roles, privileges and connections.

● Generic questionnaire and survey creator centered around a highly unique “Global Data Definitions” table enabling universal data mining, comparisons and understanding regardless of how the data is collected.

● Version control features including multi language creator, units of measure standardization and automated conversations.

● Automated assessment and survey data capture using smart phone, tablet or desktop via webpage or mobile application.

● Internal and external reporting automated directly from the central repository into desired formats using the proprietary Queryable Dataset Tool (QDT) software which integrates with Microsoft Office and Google Docs type applications allowing internal staff to compile readily accessible reports from the central repository without the requirement for system engineers or software programmers on hand.

● Automate single values, graphs and tables to be queried from the database and inserted into client reporting using programs such as Microsoft Word reports, Microsoft Power Point presentations, Google Docs and display on web pages as described above via the QDT

● Sophisticated email engine/text messaging notification software designed for scheduling any form of predetermined email/text notification, or report for example, daily, weekly or monthly. in collaboration with the generic questionnaire, survey system and interactive work-flow programs.

● Generic interactive health and medical programs creator

The generic nature of the data-capture system enables data to be collected in highly-customized formats. Data can be collected through true/false, multiple-choice, Likert scales, weights and measures including conversion from imperial to metric-enabled, numerical, date and time based, text-based collection, multi-language control. The back-end database will also allow weightings, or scores, derived from the answers to questions by the participant without the participant knowing about the scoring which we call ‘Dimensions.’ The website and mobile-entry modules are available with any typical internet browser such as Google Chrome, Safari, Firefox, IOS or Android under a secure socket layer (SSL) certificate ensuring confidentially and privacy of the data.

QHSLab data is stored in a highly-indexed document database, secured by state-of-the-art firewall technology. Triple-redundancy ensures the data is backed up and safe from accidental or malicious deletion. Furthermore, sensitive data is able to be stored in software-driven encrypted ‘obfuscated’ format for added protection. The data itself can be securely exported into any number of desired formats for the purposes of statistical analysis by external tools, including ‘big data analytics’ and by external parties if required. The web interface is serviced by a weblication created in ‘React’ which is a well proven JavaScript library for building user interfaces.

Competition

 

The market for our future solutions is highly competitive and characterized by rapid change. The competitive success of our solutions will be contingent upon our ability to provide superior solutions and a strong value proposition for all potential customers. Many existing competitors are well-established and enjoy greater resources or other strategic advantages,. It is likely that there will be new entrants into our market, some of which may become significant competitors. With the introduction of new technologies and market entrants, we expect the competitive environment to be and remain intense. We currently face competition from a range of companies, including Livongo Health, Virta Health Corp., Omada Health, Inc., Glooko, Inc., Hello Heart Inc., Lyra Health, Inc., Onduo LLC, Zillion, Inc., Lark Health and Noom, Inc.

Our main competitors fall into the following categories:

● private and public companies that offer specific chronic disease products and services, such as solutions for diabetes, hypertension, and certain addictions or behavioral health conditions;

● large enterprises who are focused on the healthcare industry, including initiatives and partnerships launched by companies which may offer or develop products or services with features or benefits that overlap with our proposed future solutions; and

● digital health device manufacturers that facilitate the collection of data but offer limited interpretation, feedback or guidance.

Many of our current competitors enjoy greater resources, recognition, deeper customer relationships, larger existing customer bases, and more mature intellectual property portfolios than we do currently.

Intellectual Property

 

Although certain of our current software applications and pioneering methods, as well as those developed in the future, will be eligible for patent and trademark protection associated with our technology platform and proprietary trade secrets, such intellectual property rights may not afford us a competitive advantage.

Government Regulation

 

Anti-Kickback Statutes

 

The federal healthcare program Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the furnishing, arranging for or recommending a good or service for which payment may be made in whole or part under a federal healthcare program such as Medicare or Medicaid. The definition of remuneration has been broadly interpreted to include anything of value, including for example gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash and waivers of payments. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals or otherwise generate business involving goods or services reimbursed in whole or in part under federal healthcare programs, the statute has been violated. The law contains a few statutory exceptions, including payments to bona fide employees, certain discounts and certain payments to group purchasing organizations. Violations can result in significant penalties, imprisonment and exclusion from Medicare, Medicaid and other federal healthcare programs. Exclusion of a manufacturer would preclude any federal healthcare program from paying for its products. In addition, kickback arrangements can provide the basis for an action under the Federal False Claims Act, which is discussed in more detail below. The Anti-Kickback Statute is broad and potentially prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry. Recognizing that the Anti-Kickback Statute is broad and may technically prohibit many innocuous or beneficial arrangements, the Office of Inspector General of Health and Human Services, or OIG, issued a series of regulations, known as the safe harbors, beginning in July 1991. These safe harbors set forth provisions that, if all the applicable requirements are met, will assure healthcare providers and other parties that they will not be prosecuted under the Anti-Kickback Statute. The failure of a transaction or arrangement to fit precisely within one or more safe harbors does not necessarily mean that it is illegal or that prosecution will be pursued. However, conduct and business arrangements that do not fully satisfy each applicable safe harbor may result in increased scrutiny by government enforcement authorities such as the OIG. Arrangements that implicate the Anti-Kickback Law, and that do not fall within a safe harbor, are analyzed by the OIG on a case- by-case basis. Government officials have focused recent enforcement efforts on, among other things, sales and marketing activities of healthcare companies, and recently have brought cases against individuals or entities with personnel who allegedly offered unlawful inducements to potential or existing customers in an attempt to procure their business. Settlements of these cases by healthcare companies have involved significant fines and/or penalties and in some instances criminal pleas. In addition to the Federal Anti-Kickback Statute, many states have their own kickback laws. Often, these laws closely follow the language of the federal law, although they do not always have the same exceptions or safe harbors. In some states, these anti-kickback laws apply with respect to all payors, including commercial health insurance companies.

False Claims Laws

 

Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, or causing to be made, a false statement to get a false claim paid. Manufacturers can be held liable under false claims laws, even if they do not submit claims to the government, if they are found to have caused submission of false claims. The Federal Civil False Claims Act also includes whistle blower provisions that allow private citizens to bring suit against an entity or individual on behalf of the United States and to recover a portion of any monetary recovery. Many of the recent highly publicized settlements in the healthcare industry related to sales and marketing practices have been cases brought under the False Claims Act. The majority of states also have statutes or regulations similar to the federal false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. Sanctions under these federal and state laws may include civil monetary penalties, exclusion of a manufacturer’s products from reimbursement under government programs, criminal fines and imprisonment.

Privacy and Security

 

In an effort to further combat healthcare fraud and protect patient confidentially, Congress included several anti-fraud measures in the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). HIPAA created a source of funding for fraud control to coordinate federal, state and local healthcare law enforcement programs, conduct investigations, provide guidance to the healthcare industry concerning fraudulent healthcare practices, and establish a national data bank to receive and report final adverse actions. HIPAA also criminalized certain forms of health fraud against all public and private insurers. Additionally, HIPAA mandates the adoption of standards regarding the exchange of healthcare information in an effort to ensure the privacy and electronic security of patient information and standards relating to the privacy of health information. Sanctions for failing to comply with HIPAA include criminal penalties and civil sanctions. In February of 2009, the American Recovery and Reinvestment Act of 2009 (“ARRA”) was signed into law. Title XIII of ARRA, the Health Information Technology for Economic and Clinical Health Act (“HITECH”), provided for substantial Medicare and Medicaid incentives for providers to adopt electronic health records (“EHRs”) and grants for the development of health information exchange (“HIE”). Recognizing that HIE and EHR systems will not be implemented unless the public can be assured that the privacy and security of patient information in such systems is protected, HITECH also significantly expanded the scope of the privacy and security requirements under HIPAA. Most notable are the new mandatory breach notification requirements and a heightened enforcement scheme that includes increased penalties, and which now apply to business associates as well as to covered entities. In addition to HIPAA, a number of states have adopted laws and/or regulations applicable in the use and disclosure of individually identifiable health information that can be more stringent than comparable provisions under HIPAA.

We believe that our future business operations will be fully compliant with applicable standards for privacy and security of protected healthcare information. We cannot predict what negative effect, if any, HIPAA/HITECH or any applicable state law or regulation will have on our business.

 

FDA Ruling: Examples of Mobile App’s which it Intends to Exclude from Regulation.

 

On September 25, 2013, the FDA issued Finalized Guidance on medical mobile applications (“Apps”). The FDA has issued a ruling on Apps that may meet the definition of a medical device, but they have determined that they will not exercise enforcement on these Apps. The Guidance contains an appendix that provides examples of mobile apps that may meet the definition of medical device but for which FDA intends to exercise enforcement discretion. These mobile apps may be intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Even though these mobile apps may meet the definition of medical device, the FDA intends to exercise enforcement discretion for these mobile apps because they pose lower risk to the public. The FDA understands that there may be other unique and innovative mobile apps that may not be covered in this list that may also constitute healthcare related mobile apps. This list is not exhaustive; it is only intended to provide clarity and assistance in identifying the mobile apps that will not be subject to regulatory requirements at this time. Based on our understanding of the Guidance, although there can be no guarantee, we believe our QHSLab services will eventually be subject to regulatory requirements because such services seem to fall within the statutory examples and therefore are treating our development within the realm of traditional medical devices subject to FDA regulations.

Property

 

Our principal executive offices are located at 901 Northpoint Parkway Suite 302, West Palm Beach, FL 33407. We are provided our office space by MedScience Research Group, Inc, an entity controlled by our CEO and Director Troy Grogan, at no cost to us.

We believe that our facilities are adequate for our current needs, but growth may require larger facilities due to anticipated addition of personnel.

Employees

 

As of December 20, 2019, we had two employees devoting substantially full-time services to the Company, the Company’s business development coordinator, and the Company’s administrative and technical development coordinator. In addition, we engage independent entities and consultants provide programming services and Quality Management System development We believe that our relationship with our employees and consultants are good.

Legal Proceedings

 

We are currently not a party to any material legal or administrative proceedings and are not aware of any pending legal or administrative proceedings against us. We may from time to time become a party to various legal or administrative proceedings arising in the ordinary course of our business.

RISK FACTORS

You should carefully consider each of the following risks and all of the other information set forth in this Form 8-K. The following risks relate principally to our business and our common stock. These risks and uncertainties are not the only ones facing our company. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business. If any of the risks and uncertainties develop into actual events, this could have a material adverse effect on our business, financial condition or results of operations. In that case, the trading price of our common stock could decline. please also see the section “Regulations and Healthcare Reform” above.

 

Risks Related to Our Business

Medical Practice Income is an early stage company with a short operating history and a relatively new business model in an emerging and rapidly evolving market, which makes it difficult to evaluate its future prospects. MPI is a pre-revenue, early stage entity and is subject to all of the risks inherent in a young business enterprise, such as, among other things, lack of market recognition and limited banking and financial relationships. As a result, we have little operating history to aid in assessing future prospects. We will encounter risks and difficulties as an early stage company in a new and rapidly evolving market. We may not be able to successfully address these risks and difficulties, which could materially harm our business and operating results.

We are an early stage company and have not yet generated significant revenues. We have not generated any revenues since our inception in March 2019. There is no assurance that we will generate sufficient revenue or ever be profitable. If planned operating levels are changed, higher operating costs encountered, more time needed to implement our plan, or less funding is received, more funds than currently anticipated may be required. Additional difficulties may be encountered during this stage of development. If additional capital is not available when required, if at all, or is not available on acceptable terms we may be forced to modify or abandon its business plan.

If we fail to raise additional capital, our ability to implement our business plan and strategy could be compromised. We have limited capital resources and operations. To date, our operations have been funded entirely from limited capital contributions and loans from our sole officer and director. We may not be able to obtain additional financing on terms acceptable to us, or at all. Even if we obtain financing for our near-term operations and product development, we may require additional capital beyond the near term. If we are unable to raise capital when needed, our business, financial condition and results of operations would be materially adversely affected, and we could be forced to reduce or discontinue our operations.

If we issue additional shares of common stock, it would reduce our stockholders’ percent of ownership and may dilute our share value. Our Certificate of Incorporation authorizes the issuance of 900 million shares of common stock. We have outstanding 5,762,735 shares of common stock. The future issuance of common stock to raise capital may result in substantial dilution in the percentage of our common stock held by our then existing stockholders. We may value any common stock issued in the future on an arbitrary basis. The issuance of common stock for future services or acquisitions or other corporate actions may have the effect of diluting the value of the shares held by our then existing stockholders, and might have an adverse effect on any trading market for our common stock.

Our business model is unproven with no assurance of significant revenues or operating profit. Our current business model is unproven and the profit potential, if any, is unknown at this time. We are subject to all of the risks inherent in the creation of a new business. There can be no assurance that our results of operations or business strategy will achieve significant revenue or profitability.

Our cloud based software platform under development is new and unproven. We are in the initial phase of developing a unique Cloud Based Software as a Medical Service (SaaMS) platform that is new and unproven that will focus on value-based healthcare, informatics and algorithmic personalized medicine including digital therapeutics, behavior based remote patient monitoring, chronic care and preventive medicine. The market for our solutions is relatively new and evaluating the size and scope of the market is subject to risks and uncertainties. Our future success will depend in large part on the growth of this market. Potential customers may not recognize the need for, or benefits of, our platform, which may prompt them to adopt alternative products and services to satisfy their healthcare requirements. Assessing the market we are competing in for our solutions, or planning to compete in, is particularly difficult due to a number of factors, including limited available information and rapid evolution of the market. If our market does not experience significant growth, or if demand for our platform does not occur, then our business, results of operations and financial condition will be adversely affected.

Dependence on Key Existing and Future Personnel. Our success will depend, to a large degree, upon the efforts and abilities of our officer and key consultancy service providers. The loss of the services of one or more of our key providers could have a material adverse effect on our operations. In addition, as our business model is implemented, we will need to recruit and retain additional management, key employees and consulting service providers in virtually all phases of our operations. Key employees and consultants will require a strong background in our industry. We cannot assure that we will be able to successfully attract and retain key personnel.

We operate in a highly competitive industry. We encounter competition from local, regional or national entities, some of which have superior resources or other competitive advantages. Intense competition may adversely affect our business, financial condition or results of operations. Our competitors may be larger and more highly capitalized, with greater name recognition. We will compete with such companies on brand name, quality of services, level of expertise, advertising, product and service innovation and differentiation of product and services. As a result, our ability to secure significant market share may be impeded.

We have engaged in limited product development activities and our product development efforts may not result in commercial products. We intend to build out the technology platform necessary to execute our planned business strategy. Of course, there may be other factors that prevent us from marketing a product including, but not limited to, our limited cash resources. We cannot guarantee we will be able to produce commercially successful products. Further, our eventual operating results could be susceptible to varying interpretations by potential customers, or scientists, medical personnel, regulatory personnel, statisticians and others, which may delay, limit or prevent our executing our proposed business plan.

We face substantial competition, and others may discover, develop, acquire or commercialize products before or more successfully than we do. We operate in a highly competitive environment. Our products compete with other products or treatments for diseases for which our products may be indicated. Other healthcare companies have greater clinical, research, regulatory and marketing resources than us. In addition, some of our competitors may have technical or competitive advantages for the development of technologies and processes. These resources may make it difficult for us to compete with them to successfully discover, develop and market new products.

The growth of our business relies, in part, on the growth and success of our clients. The utility of our products to our clients will be determined by their ability to incorporate them into their health care regimen and the acceptance of our products by their patients. The ability of our clients to incorporate our products into their practices is outside of our control. In addition, if the number of patients of one or more of our client’s using our products were to be reduced, such decrease would lead to a decrease in our revenue.

 

We will conduct business in a heavily regulated industry and if we fail to comply with applicable laws and government regulations, we could incur penalties or be required to make significant changes to our operations or experience adverse publicity, which could have a material adverse effect on our business, financial condition, and results of operations. The healthcare industry is heavily regulated and closely scrutinized by federal, state and local governments. Comprehensive statutes and regulations govern the products we offer and the manner in which we provide and bill for services and collect reimbursement from governmental programs and private payors, our contractual relationships with our providers, vendors and clients, our marketing activities and other aspects of our operations. Of particular importance are:

Our use and disclosure of personally identifiable information, including health information, is subject to federal and state privacy and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could result in significant liability or reputational harm and, in turn, a material adverse effect on our client base, membership base and revenue. Numerous state and federal laws and regulations govern the collection, dissemination, use, privacy, confidentiality, security, availability and integrity of personally identifiable information (PII), including protected health information (PHI). These laws and regulations include HIPAA. HIPAA establishes a set of basic national privacy and security standards for the protection of PHI, by health plans, healthcare clearinghouses and certain healthcare providers, referred to as covered entities, and the businesses with whom such covered entities contract for services, which includes us. HIPAA requires healthcare providers like us to develop and maintain policies and procedures with respect to PHI that is used or disclosed, including the adoption of administrative, physical and technical safeguards to protect such information. HIPAA also implemented the use of standard transaction code sets and standard identifiers that covered entities must use when submitting or receiving certain electronic healthcare transactions, including activities associated with the billing and collection of healthcare claims. HIPAA imposes mandatory penalties for certain violations which can be significant. However, a single breach incident can result in violations of multiple standards. HIPAA also authorizes state attorneys general to file suit on behalf of their residents. Courts will be able to award damages, costs and attorneys’ fees related to violations of HIPAA in such cases. The standards established in HIPAA have been used as the basis for duty of care in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI. In addition, HIPAA mandates that the Secretary of Health and Human Services, or HHS conduct periodic compliance audits of HIPAA covered entities or business associates. It also tasks HHS with establishing a methodology whereby individuals who were the victims of breaches of unsecured PHI may receive a percentage of the Civil Monetary Penalty fine paid by the violator. HIPAA further requires that patients be notified of any unauthorized acquisition, access, use or disclosure of their unsecured PHI that compromises the privacy or security of such information, with certain exceptions related to unintentional or inadvertent use or disclosure by employees or authorized individuals. If a breach affects 500 patients or more, it must be reported to HHS without unreasonable delay, and HHS will post the name of the breaching entity on its public web site. Breaches affecting 500 patients or more in the same state or jurisdiction must also be reported to the local media. If a breach involves fewer than 500 people, the covered entity must record it in a log and notify HHS at least annually. Numerous other federal and state laws protect the confidentiality, privacy, availability, integrity and security of personally identifiable information, or PII, including PHI. These laws in many cases are more restrictive than, and may not be preempted by, the HIPAA and may be subject to varying interpretations by courts and government agencies, creating complex compliance issues for us and our clients potentially exposing us to additional expense, adverse publicity and liability. New health information standards could have a significant effect on the manner in which we must handle healthcare related data, and the cost of complying with standards could be significant. If we do not comply with existing or new laws and regulations related to PHI, we could be subject to criminal or civil sanctions. Because of the extreme sensitivity of the PII we store and transmit, the security features of our technology platform are very important. If our security measures, some of which are managed by third parties, are breached or fail, unauthorized persons may obtain access to sensitive client and patient data, including HIPAA-regulated PHI. As a result, our reputation could be severely damaged, adversely affecting client and patient confidence. Clients may curtail their use of or stop using our services or our client base could decrease, which would cause our business to suffer. In addition, we could face litigation, damages for contract breach, penalties and regulatory actions for violation of HIPAA and other applicable laws or regulations and significant costs for remediation, notification to individuals and for measures to prevent future occurrences. Any potential security breach could also result in increased costs associated with liability for stolen assets or information, repairing system damage that may have been caused by such breaches, incentives offered to clients or other business partners in an effort to maintain our business relationships after a breach and implementing measures to prevent future occurrences, including organizational changes, deploying additional personnel and protection technologies, training employees and engaging third-party experts and consultants. While we maintain insurance covering certain security and privacy damages and claim expenses, we may not carry insurance or maintain coverage sufficient to compensate for all liability and in any event, insurance coverage would not address the reputational damage that could result from a security incident. We outsource important aspects of the storage and transmission of client and patient information, and thus rely on third parties to manage functions that have material cyber-security risks. We attempt to address these risks by requiring outsourcing subcontractors who handle client and patient information to sign business associate agreements contractually requiring those subcontractors to adequately safeguard personal health data to the same extent that applies to us and in some cases by requiring such outsourcing subcontractors to undergo third-party security examinations. However, we cannot assure you that these contractual measures and other safeguards will adequately protect us from the risks associated with the storage and transmission of client and patient proprietary and protected health information. In addition, various states have enacted laws governing the privacy of personal information collected and used by businesses online. For example, California has recently adopted the California Consumer Privacy Act of 2018, which goes into effect on January 1, 2020. This law, in part, requires that companies make certain disclosures to consumers via their privacy policies, or otherwise at the time the personal data is collected. The Company will have to determine what personal data it is collecting from individuals and for what purposes, and to update its privacy policy every 12 months to make the required disclosures, among other things. Since this law is newly enacted and has not yet gone into effect, it is unclear whether it will have any material impact on the Company’s business and operations.

 

 

The security of our platform, networks or computer systems may be breached, and any unauthorized access to our customer data will have an adverse effect on our business and reputation. The use of our products will involve the storage, transmission and processing of our clients’ and their patients’ private data, and this data may contain confidential and proprietary information of our clients and their patients’ or other personal or identifying information regarding our clients, and their patients’, their employees or other persons. Individuals or entities may attempt to penetrate our network or platform security, or that of our third-party hosting and storage providers, and could gain access to our clients’ and their patients’ private data, which could result in the destruction, disclosure or misappropriation of proprietary or confidential information of our clients’ and their patients’ or their customers, employees and business partners. If any of our clients’ private data is leaked, obtained by others or destroyed without authorization, it could harm our reputation, we could be exposed to civil and criminal liability, and we may lose our ability to access private data, which will adversely affect the quality and performance of our platform. In addition, our platform may be subject to computer malware, viruses and computer hacking, fraudulent use attempts and phishing attacks, all of which have become more prevalent in our industry. Though it is difficult to determine what, if any, harm may directly result from any specific interruption or attack, they may include the theft or destruction of data owned by us or our customers, and/or damage to our platform. Any failure to maintain the performance, reliability, security and availability of our products or services and technical infrastructure to the satisfaction of our clients may harm our reputation and our ability to retain existing customers and attract new users. While we will implement procedures and safeguards that are designed to prevent security breaches and cyber-attacks, they may not be able to protect against all attempts to breach our systems, and we may not become aware in a timely manner of any such security breach. Unauthorized access to or security breaches of our platform, network or computer systems, or those of our technology service providers, could result in the loss of business, reputational damage, regulatory investigations and orders, litigation, indemnity obligations, damages for contract breach, civil and criminal penalties for violation of applicable laws, regulations or contractual obligations, and significant costs, fees and other monetary payments for remediation. If customers believe that our platform does not provide adequate security for the storage of sensitive information or its transmission over the Internet, our business will be harmed. Customers’ concerns about security or privacy may deter them from using our platform for activities that involve personal or other sensitive information.

To the extent we use “open source” software, our use could adversely affect our ability to offer our services and subject us to possible litigation. We may use open source software in connection with our products and services. Companies that incorporate open source software into their products have, from time to time, faced claims challenging the use of open source software and/or compliance with open source license terms. As a result, we could be subject to suits by parties claiming ownership of what we believe to be open source software or claiming noncompliance with open source licensing terms. Some open source software licenses require users who distribute software containing open source software to publicly disclose all or part of the source code to such software and/or make available any derivative works of the open source code, which could include valuable proprietary code of the user, on unfavorable terms or at no cost. While we monitor the use of open source software and try to ensure that none is used in a manner that would require us to disclose our proprietary source code or that would otherwise breach the terms of an open source agreement, such use could inadvertently occur, in part because open source license terms are often ambiguous. Any requirement to disclose our proprietary source code or pay damages for breach of contract could have a material adverse effect on our business, financial condition and results of operations and could help our competitors develop products and services that are similar to or better than ours.

Assertions by third parties of infringement or other violations by us of their intellectual property rights could result in significant costs and harm our business and operating results. Our success depends upon our ability to refrain from infringing upon the intellectual property rights of others. Some companies, including some of our competitors, own large numbers of patents, copyrights and trademarks, which they may use to assert claims against us. As we grow and enter new markets, we will face a growing number of competitors. As the number of competitors in our industry grows and the functionality of products in different industry segments overlaps, we expect that software and other solutions in our industry may be subject to such claims by third parties. Third parties may in the future assert claims of infringement, misappropriation or other violations of intellectual property rights against us. We cannot assure you that infringement claims will not be asserted against us in the future, or that, if asserted, any infringement claim will be successfully defended. A successful claim against us could require that we pay substantial damages or ongoing royalty payments, prevent us from offering our services, or require that we comply with other unfavorable terms. We may also be obligated to indemnify our customers or business partners or pay substantial settlement costs, including royalty payments, in connection with any such claim or litigation and to obtain licenses, modify applications or refund fees, which could be costly. Even if we were to prevail in such a dispute, any litigation regarding our intellectual property could be costly and time-consuming and divert the attention of our management and key personnel from our business operations.

Risks Related to Regulation

 

Our products may be subject to product liability legal claims, which could have an adverse effect on our business, results of operations and financial condition. Certain of our products provide applications that relate to patient clinical information. Any failure by our products to provide accurate and timely information concerning patients, their medication, treatment and health status, generally, could result in claims against us which could materially and adversely impact our financial performance, industry reputation and ability to market new system sales. In addition, a court or government agency may take the position that our delivery of health information directly, including through licensed practitioners, or delivery of information by a third party site that a consumer accesses through our websites, exposes us to assertions of malpractice, other personal injury liability, or other liability for wrongful delivery/handling of healthcare services or erroneous health information. We anticipate that in the future we will maintain insurance to protect against claims associated with the use of our products as well as liability limitation language in our end-user license agreements, but there can be no assurance that our insurance coverage or contractual language would adequately cover any claim asserted against us. A successful claim brought against us in excess of or outside of our insurance coverage could have an adverse effect on our business, results of operations and financial condition. Even unsuccessful claims could result in our expenditure of funds for litigation and management time and resources.

Certain healthcare professionals who use our Cloud-based products will directly enter health information about their patients including information that constitutes a record under applicable law that we may store on our computer systems. Numerous federal and state laws and regulations, the common law and contractual obligations, govern collection, dissemination, use and confidentiality of patient-identifiable health information, including: