The Health Insurance Portability and Accountability Act of 1996 currently does not apply to us, and hence our members’ Member Data will not be protected by that law.
We are not subject to the Health Insurance Portability and Accountability Act of 1996, as amended, commonly known as HIPAA, even though we will have access to, store, process and transmit sensitive personal, health and medical information, because we are not a “covered entity” for purposes of that statute. HIPAA is designed to protect medical records and other personal health information by limiting their use and disclosure, giving patients the right to access, amend and seek accounting of their own health information and limiting most uses and disclosures of health information to the minimum amount reasonably necessary to accomplish the intended purpose. Various government agencies may enforce these provisions of HIPAA and impose civil or criminal penalties for HIPAA violations. Because we are not subject to HIPAA, we will not be subject to the civil and criminal penalties available to government agencies and, accordingly, we may not have the same incentive to protect Member Data as would a covered entity subject to HIPAA’s requirements.
Our current lack of geographic diversity exposes us to risk.
Our operations are currently geographically limited to the United States and we are currently only accepting members who are resident in the United States. As a result of this geographical concentration, our Database may lack data diversification desired by our customers. We plan to expand our operations and member admissions internationally in order to increase the diversity of our Database, and if and when we do, such expansion would subject us to additional laws and regulations, such as data privacy, health and securities laws and regulations, place increased responsibilities on our Manager, divert resources from other operations and expose us to new risks of foreign operations.
We will depend upon third parties to generate Member Data who may become our direct competitors if they determine that they could create an ecosystem that competes with our Database.
Our ability to grow the Database depends on our ability to draw individuals to provide us with Member Data. Many types of Member Data must be generated by third parties, who provide it to potential members who then submit it to us. We will therefore depend on these third parties to provide consistent and reliable Member Data. These third parties could increase the costs to obtain Member Data or seek to interfere with potential members’ ability to provide the Member Data to us. Additionally, some of these third parties are, or could become, our direct competitors, if they determine that they could create an ecosystem to compete with our Database.
If we experience excessive rates of member attrition, our ability to attract customers or to enable genomic discovery could fail.
Members may elect to have their Member Data purged from our Database at any time. We must continually add new members both to replace members who choose to purge their data and to increase our member base. Members may choose to purge their Member Data for many reasons. If members are concerned about privacy and security and do not perceive our services to be reliable, if we fail to keep members engaged and interested in our mission and purpose, if we fail to generate sufficient cash to make distributions to members, or if we simply lose our members’ attention, we could fail to populate the Database with sufficient Member Data and our ability to earn revenues may be materially affected.
If members to do not recurrently provide us with certain types of Member Data, we could fail create a longitudinal database.
Certain types of our Member Data, such as personal fitness data or nutrition data will need to be contributed by Members recurrently in order for such data to provide full value to our potential customers. If our members fail to provide us with suitable longitudinal data, we will not be create a longitudinal Database and our ability to earn revenues may be materially affected.
Unfavorable media coverage could negatively affect our business.
Unfavorable publicity regarding, for example, our privacy practices, terms of service, regulatory activity, the actions of third parties, the use of our products or services for illicit, objectionable, or illegal ends or the actions of other companies that provide similar services to us, could adversely affect our reputation. Such negative publicity also could have an adverse effect on the size, engagement, and loyalty of our member base and result in member attrition and decreased revenue, which could adversely affect our business and financial results.
Because the market for genomic information is relatively new and rapidly evolving, we may become subject to additional future governmental regulation, which may place additional cost and time burdens on our operations.
We are subject, both directly and indirectly, to the adverse impact of existing and potential future government regulation of our operations and markets. The life sciences and pharmaceutical industries, which are significant target markets for our services, have historically been heavily regulated. There are comprehensive federal and state laws regarding matters such as the privacy of patient information and research in genetic engineering.
Legislative bodies or regulatory authorities may extend existing or adopt additional laws and regulations that adversely affect our market opportunities or services. Regulatory approval processes may be expensive, time-consuming and uncertain, and our failure to obtain or comply with these approvals or clearances could harm our business, financial condition or operating results.
We may face competition from a number of different sources, and our failure to compete effectively could materially impact our revenues, results of operations and financial condition.
We face competition in our business from a variety of organizations. If we fail to meet our members’ expectations, we could fail to retain existing or attract new members, either of which could harm our business and results of operations.
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