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Hyperfine, Inc
Accounting and Auditing Matters The unethical systematic recording and analysis of the business and financial transactions associated with generally accepted accounting practices. (Examples include: misstatement of revenues, misstatement of expenses, misstatement of assets, misapplications of GAAP principles, wrongful transactions.)
Clinical Trials Misconduct in connection with any clinical trial, for instance, falsifying any study results or reports; failure to maintain adequate documentation as required by the IRB-approved study protocol; failure to follow the IRB study protocol; making a false or misleading statement in any material submitted to an IRB; making a false or misleading statement in any study report or other documentation, including the failure to report negative results; violation of adverse event reporting requirements; violation of FDA or ICH standards for the conduct of human clinical trials (e.g., ICH E6 Good Clinical Practices Consolidated Guidance or 21 C.F.R. parts 50, 54, 56).
Conflict of Interest A conflict of interest is defined as a situation in which a person, such as a public official, an employee, or a professional, has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties. (Examples include: inappropriate vendor relations, bribery, misuse of confidential information, inappropriate customer relations)
Disclosure of Confidential Information Unauthorized and unlawful disclosure of corporately owned intellectual property or trade secrets, as well as employee, customer or consumer information, marketing and other corporate data bases, marketing plans, business proposals and strategies.
Discrimination or Harassment Uninvited and unwelcome verbal or physical conduct directed at an employee because of his or her sex, religion, ethnicity, or beliefs. (Examples include: bias in hiring, bias in assignments, wrongful termination, bias in promotions, bias in educational decisions, unfair compensation, inappropriate language).
Embezzlement To appropriate (as property entrusted to one's care) fraudulently to one's own use. (Examples include: bookkeeping errors, misapplication of funds, and mishandling of cash)
Failure to Comply with Quality, Regulatory, or Manufacturing Standards Any violation of the pharmaceutical or biological products cGMPs or company standards regarding Manufacturing, Laboratory Practices, Clinical Practices and other applicable government regulations and guidelines. Any violation of applicable cGMPs (21 C.F.R. parts 210, 211, 600, 610)
Falsification of Contracts, Reports or Records Falsification of records consists of altering, fabricating, falsifying, or forging all or any part of a document, contract or record for the purpose of gaining an advantage, or misrepresenting the value of the document, contract or record.
Gifts and Entertainment Refers to the inappropriate offering, solicitation or accepting of items of more than nominal value from vendors, customers or other third parties in a capacity as an employee of the Company.
Health Insurance Portability and Accountability Act This Category should be selected if there is a concern with the improper use or disclosure of Protected Health Information. Protected Health Information is information that: (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and (i) that identifies the individual; or (ii) for which there is a reasonable basis to believe the information can be used to identify the individual.
Improper Lobbying or Political Contribution Inappropriate activities in violation of federal and state lobbying and political action, including the contribution or acceptance of funds meant for another candidate or the improper use of contributed funds for personal gain.
Misconduct or Inappropriate Behavior Intentional wrongdoing; specifically: deliberate violation of a law or standard.
PhRMA Code on Interactions with Healthcare Professionals Any violation of the Pharmaceutical Research and Manufacturers Association ("PhRMA") Code on Interactions with Healthcare Professionals.
Questionable Discounts A "discount" is a price concession, regardless of its form. "Questionable discounts" are those that are not part of an "arms-length" transaction, that are hidden or not properly documented on the invoice or that are given on an item or services in exchange for the purchase of a different item or service. A "hidden" and therefore "questionable discount" can be in the form of "value added" services or in the provision of other valuable items or services that are provided to the purchaser for no or reduced cost when the purchaser buys a product.
Research or Educational Grant Misconduct Sham or other improper research or educational grants used to induce or reward the purchase or prescription of Company products or to market improperly a Company product.
Sabotage or Vandalism Destruction of an employer's property (as tools or materials) or the hindering of manufacturing by discontented workers (Examples include: Equipment destruction, stealing, work slowdown, computer virus)
Safety, Health and the Environment Failure to provide a safe working environment or training required by company policies; failure to report accidents, etc. concealing of actual or potential environmental damage; failure to comply with environmental laws.
Securities Violations Infringement, transgression; specifically: an infringement of the rules which securities acts define. (Examples include: insider trading)
Substance Abuse Substance abuse is defined as the misuse of both legal and illegal drugs including alcohol. (Examples include: cocaine, narcotics, marijuana, stimulants)
Theft The act of stealing; specifically: the felonious taking and removing of personal property with intent to deprive the rightful owner of it.
Violence or Threat Violence is an expression of the intention to inflict evil, injury, or damage to a person or their property. (Examples include: direct, veiled, conditional, violent)
Other If you feel that the definitions above do not describe the event, action or situation you are looking to report about, please use this header.