Corporate Compliance Services
Our lawyers provide comprehensive corporate compliance representation for healthcare companies of all sizes.
From corporate structuring and governance to federal statutory and regulatory compliance, we can make sure your healthcare company is positioned for long-term stability and success.
Corporate compliance is a top legal concern for companies of all sizes and across all sectors and industries – or at least it should be. With the risks of non-compliance being as great as they are, healthcare company leaders need to make sure that they are doing everything necessary to mitigate their risk of employee and competitor lawsuits, regulatory enforcement actions, and federal civil and criminal prosecutions. While companies’ compliance efforts can (and generally should) run in the background, maintaining compliance need to remain a priority for executive leadership at all times – as even “minor” missteps and oversights have the potential to lead to significant consequences.
Our lawyers provide comprehensive corporate compliance representation. Our firm’s practice is nationwide in scope, and our clients range from physician groups and other professional practices to large corporate organizations. Included among our senior attorneys are several former federal prosecutors who have particular experience in numerous areas of federal statutory and regulatory compliance, and our team also includes non-lawyer experts who specialize in matters ranging from general corporate compliance to U.S. Department of Labor (DOL) compliance and other federal compliance matters.
What Does it Take to Be Compliant?
In today’s legal and regulatory landscape, compliance is a constantly-shifting target, and companies’ compliance obligations can be as varied as the products they sell and the clients they serve. As a result, in order to establish compliance – and, equally important, to prove that they are compliant when called upon to do so – companies must develop and implement custom-tailored compliance programs that reflect the unique aspects of their businesses. For example, factors that will affect a company’s corporate compliance needs include:
- Corporate structure, ownership structure, and governance model
- Workforce size and organizational structure
- Product and service lines
- Geographic scope of business operations and marketing reach
- Environmental impact
As a general rule, larger companies will need to devote more time and effort. In fact, many federal statutes and regulations (including federal data breach response regulations) expressly take company size into account when determining the lengths to which corporate organizations must go in order to be compliant. However, all companies have compliance obligations; and, regardless of a company’s size or needs, the costs of compliance will generally pale in comparison to the financial loss and reputational harm that can attend to a highly-publicized compliance failure.
So, what does it take to be compliant? While every company will have its own answer, the core components of an effective corporate compliance program typically include:
1. Corporate Structural and Organizational Assessment
Assessment of a company’s compliance needs should start at the entity level. What made sense when your company was founded five (or fifty) years ago might not make sense today. Determining what is necessary from a corporate structuring and governance perspective should be one of the first steps toward assessing a company’s compliance needs, and your company’s compliance counsel will need to have a thorough understanding of your company’s organizational and reporting structure as well.
2. Risks and Needs Assessment
As we mentioned, no two companies’ compliance needs are exactly alike. As a result, in order to develop an effective compliance program, you first need to gain a clear understanding of your company’s specific needs. Is your company subject to federal securities laws or the Foreign Corrupt Practices Act (FCPA)? What about federal environmental regulations or the General Data Protection Regulation (GDPR)? If you don’t know the answers to these questions, you have no way of knowing whether your company is meeting its compliance obligations.
3. Compliance Program Documentation
With a clear understanding of your company’s risks and needs, you are now equipped to develop a comprehensive compliance program. Companies’ compliance documents should be detailed, specific, and custom-tailored to their specific compliance obligations.
While many companies will have similar obligations (i.e. all large employers are subject to federal anti-discrimination and anti-harassment laws), they will still need to address these obligations in ways that reflect their unique leadership model, organizational structure, and corporate culture. With regard to less-ubiquitous obligations such as FCPA and Food, Drug and Cosmetic Act (FDCA) compliance, companies’ compliance documents should speak to the specific provisions of the law that apply to their business operations.
4. Compliance Program Training and Implementation
A corporate compliance program is meaningless if it sits on the shelf. In order to mitigate their risk of penalties and liability in the event of a federal investigation or civil lawsuit, companies must implement their compliance programs on an organization-wide basis – and they must document their efforts to do so. Corporate compliance is not just about documentation. It is about actual compliance. In fact, failing to adequately implement a documented compliance program can be just as dangerous as failing to put a program in place, if not more so.
5. Compliance Monitoring and Enforcement
Monitoring and enforcement are key aspects of an effective corporate compliance program as well. The company’s chief compliance officer or oversight board should have a clearly-defined role, and this role should be executed consistently and effectively without influence from competing corporate interests. Employees who violate the company’s code of conduct or compliance policies should be disciplined accordingly, and any systemic issues that are identified should be remedied immediately.
6. Event Response Preparedness and Execution
If an issue arises that has implications beyond employee discipline and internal remediation, the company must be prepared to act quickly. Various federal statutes and regulations incorporate response provisions into their compliance requirements, and companies may be required to disclose violations to federal authorities, their clients or customers, or the public at large. However, before taking these types of measures, companies must be certain that they are necessary, and they must have a clear and executable plan that involves acting on the advice of the company’s compliance counsel.
Protecting your brand and trade secrets, enhancing due diligence, enforcing workplace policies, optimizing your computer network against attacks, and preventing or uncovering fraud are the five key areas of our corporate compliance approach. I’m attorney Nick Oberheiden.
There are different times and circumstances a corporate compliance boost may be needed. Some clients call us after they were just notified about a lawsuit, a government audit, or a formal investigation. Other clients contact us more preemptively; for example, a new management wants to make sure that the company is healthy and protected from within.
In either scenario, you can count on us. We’re not going to send you some young associates who will bill you for running around with notepads. When you work with us, you will work with former Justice Department officials, former FBI agents, former secret service agents, and true professionals whose credibility and credentials will benefit your compliance.
10 Critical Areas of Federal Corporate Compliance
In order to develop an effective compliance program, compliance counsel must have an in-depth understanding of all of the federal laws, rules, and regulations that are potentially applicable to a company’s operations. At Oberheiden, P.C., our compliance lawyers and consultants bring centuries of combined experience to helping companies meet their legal obligations. This includes helping our corporate clients address critical areas such as:
- Antitrust Compliance – Federal antitrust laws regulate the competitive aspects of business, and companies can face federal enforcement action and private litigation as a result of a broad range of antitrust violations.
- Consumer Finance Compliance – Consumer lending, fair credit reporting, credit card rules, and various other aspects of consumer financial services are heavily regulated at the federal level.
- Data Security Compliance – State, federal, and international laws and regulations create an extraordinarily-complex set of data security compliance obligations for companies of all sizes.
- Employment Law Compliance – Federal law prohibits employment discrimination on the basis of an employee’s race, color, ethnicity, gender, sexual orientation, age, or other protected classification. Sexual harassment is considered a form of discrimination, and companies can face substantial liability for the acts of their employees.
- Environmental Compliance – Environmental compliance issues can arise under a broad range of circumstances. We are able to assist clients with matters ranging from hazardous waste disposal to Superfund compliance.
- FCPA Compliance – The compliance burdens under the FCPA can be substantial, and many companies are unaware that they are subject to the law’s prohibitions and requirements. We assist companies with FCPA compliance in their domestic and international business operations.
- FDCA Compliance – Establishing compliance with the FDCA can present a number of different challenges. We help drug makers, medical device companies, and other clients with all compliance matters falling within the jurisdiction of the U.S. Food and Drug Administration (FDA).
- Federal Trade Commission (FTC) Compliance – FTC compliance covers issues in the areas of advertising (including false, deceptive, and unsubstantiated marketing claims), electronic commerce, and certain aspects of consumer finance and data protection. The FTC actively enforces companies’ compliance obligations and violations can lead to substantial penalties.
- Industry–Specific Compliance – From healthcare to transportation, companies operating in a broad range of industries are subject to industry-specific compliance obligations. Industry-specific laws and regulations can present substantial compliance burdens and can have a direct impact on companies’ day-to-day operations.
- Securities Compliance – Public companies are not the only ones that have federal securities law compliance obligations. Private placements, equity investments, and other transactions that can be classified as the issuance of securities under federal law can create substantial risk exposure if not structured and managed effectively.
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Contact the Corporate Compliance Lawyers at Oberheiden, P.C.
If you would like more information about our firm’s corporate compliance practice, we encourage you to get in touch. Our federal lawyers and consultants have a proven track record of helping clients develop and implement comprehensive compliance programs that are capable of fully withstanding federal scrutiny during audits and investigations. To speak with a member of our firm in confidence, please call 888-680-1745 or request a complimentary initial consultation online now.
Nick Oberheiden: Corporate Compliance Lawyer