Graduate Certificate Programs

Students will learn to:

• Interpret relevant statutes, case law, and regulations pertaining to biotechnology
• Assess incentives for innovation, such as federal funding, licensing, and patents
• Evaluate ethical considerations related to biotechnology and the mechanisms that exist for addressing them
• Identify legal and policy issues resulting from “dual use” research

Students will learn to:

• Identify the laws, regulations, and standards to which clinical research sponsors are expected to comply, both in the United States and globally
• Evaluate factual scenarios to identify compliance risks and develop strategies for responding to them
• Assess the strengths and weaknesses of proposals to expand, reduce, or modify research sponsors’ compliance obligations

Students will learn to:

• Navigate the maze of regulatory requirements applicable to clinical research with human participants
• Evaluate proposed research projects to determine whether they meet the criteria for institutional review board (IRB) approval
• Analyze proposed regulatory changes and assess their potential impact on researchers, research subjects, institutions, and sponsors

Students will learn to:

• Identify key sources of law applicable to drug and device advertising and promotion and explain what companies must do to comply with these requirements
• Distinguish between off-label promotion and scientific and educational exchanges
• Recognize the impact of transparency and disclosure requirements on companies’ relationships with healthcare providers
• Develop strategies for avoiding government enforcement action by designing policies and practices that reflect legal requirements
• Assess the industry’s approach to self-regulation and discuss the opportunities and risks of using social media platforms for advertising, promotion, and patient relations

Students will learn to:

• Identify the primary legal, regulatory, and ethical standards with which pharmaceutical and medical device companies must comply
• Articulate best practices in corporate compliance in the life sciences industry
• Assess the risks of various business strategies and transactions from a fraud and abuse perspective

Students will learn to:

• Identify key sources of law applicable to the Internet as a decentered, community-standards focused network system
• Assess risks to cybersecurity from mismanagement, crime, terrorism, and war
• Evaluate proposed changes in the law related to cybersecurity and assess their implications for the industry and civil society

Prerequisite: INDL7550 Cybersecurity I

Students will learn to:

• Apply industry-leading data security and privacy compliance frameworks to realistic examples
• Conduct qualitative and quantitative cyber risk assessments and transfer cyber risks
• Prepare for and comply with legal requirements relating to data breaches and other legal process for digital information

Students will learn to:

• Apply the European Union's General Data Protection Regulation (GDPR) to different business practices and technologies
• Incorporate key principles of European human rights law into an analysis of data protection practices and policies
• Anticipate future directions in the evolution of European data protection and information privacy law

Students will learn to:

• Recognize the differences between the FDA’s approach to pre-market authorization of drugs, biologics, and devices
• Evaluate how the FDA enforces its regulatory requirements and the implications of enforcement mechanisms for individuals and companies
• Explain when state tort claims against drug and device manufacturers are preempted by federal law and when they are not

Students will learn to:

• Identify red flags in business activities that would require further assessment for compliance with anti-corruption laws
• Analyze company activities to determine whether they violate the U.S Foreign Corrupt Practices Act, the UK Bribery Act, or other laws
• Articulate the key elements of a global anti-corruption compliance program

Students will learn to:

• Evaluate and determine whether a given authorization, privacy policy or business associate agreement complies with HIPAA
• Identify and articulate the potential enforcement methods and outcomes and the requirements for breach notification
• Assess and critique the regulatory choices made under HIPAA

Students will learn to:

• Identify and analyze common medical situations involving minors that may raise legal and ethical dilemmas
• Evaluate who has the authority to consent to health care for a minor in different situations
• Recognize situations in which health care providers should notify child protective services or seek judicial guidance
• Propose reforms to address current public health issues affecting minors

Students will learn to:

• Identify the laws, regulations, and standards to which clinical research sponsors are expected to comply, both in the United States and globally
• Evaluate factual scenarios to identify compliance risks and develop strategies for responding to them
• Assess the strengths and weaknesses of proposals to expand, reduce, or modify research sponsors’ compliance obligations

Students will learn to:

• Navigate the maze of regulatory requirements applicable to clinical research with human participants
• Evaluate proposed research projects to determine whether they meet the criteria for institutional review board (IRB) approval
• Analyze proposed regulatory changes and assess their potential impact on researchers, research subjects, institutions, and sponsors

Students will learn to:

• Assess the impact of existing and proposed laws and policies on patient safety and quality
• Appreciate the intersection of nonprofit corporation law, laws governing state and federal tax exemptions, and federal fraud and abuse laws
• Design effective and compliant peer review and credentialing processes
• Identify key statutes, regulation, and guidance documents that impose compliance obligations

Students will learn to:

• Identify key sources of law applicable to the Internet as a decentered, community-standards focused network system
• Assess risks to cybersecurity from mismanagement, crime, terrorism, and war
• Evaluate proposed changes in the law related to cybersecurity and assess their implications for the industry and civil society

Prerequisite: INDL7550 Cybersecurity I

Students will learn to:

• Apply industry-leading data security and privacy compliance frameworks to realistic examples
• Conduct qualitative and quantitative cyber risk assessments and transfer cyber risks
• Prepare for and comply with legal requirements relating to data breaches and other legal process for digital information

Students will learn to:

• Apply the European Union's General Data Protection Regulation (GDPR) to different business practices and technologies
• Incorporate key principles of European human rights law into an analysis of data protection practices and policies
• Anticipate future directions in the evolution of European data protection and information privacy law

Students will learn to:

• Identify red flags in business activities that would require further assessment for compliance with anti-corruption laws
• Analyze company activities to determine whether they violate the U.S Foreign Corrupt Practices Act, the UK Bribery Act, or other laws
• Articulate the key elements of a global anti-corruption compliance program

Students will learn to:

• Evaluate and determine whether a given authorization, privacy policy or business associate agreement complies with HIPAA
• Identify and articulate the potential enforcement methods and outcomes and the requirements for breach notification
• Assess and critique the regulatory choices made under HIPAA

Students will learn to:

• Examine complex issues in health care from a bioethical perspective
• Distinguish different schools of bioethical thought
• Construct rigorous ethical analyses of contemporary healthcare issues

Students will learn to:

• Assess practical fact patterns in order to issue-spot potential areas of non-compliance
• Identify the potential repercussions of a Stark Law violation and manage practical situations to reduce the risk of legal exposure
• Analyze the potential implications of the Stark Law on structuring compliant physician arrangements, particularly in light of healthcare reform

Students will learn to:

• Recognize the factors that trigger the creation of a provider-patient relationship
• Explain the legal obligations of hospitals and healthcare providers when patients arrive at an emergency department
• Advise healthcare providers on how to comply with the HIPAA Privacy Rule

Students will learn to:

• Articulate the goals of an internal investigation and the various steps necessary to achieve those goals
• Identify actions that ought to be taken at the outset of an investigation to preserve documents and confidentiality and prevent further liability risks
• Appreciate the nature and extent of legal constraints on conducting investigatory interviews
• Analyze what, if any, actions to take on the basis of the facts uncovered during an internal investigation
• Describe potential variations in state and national laws potentially affecting workplace investigations

Students will learn to:

• Identify key sources of law applicable to the Internet as a decentered, community-standards focused network system
• Assess risks to cybersecurity from mismanagement, crime, terrorism, and war
• Evaluate proposed changes in the law related to cybersecurity and assess their implications for the industry and civil society

Prerequisite: INDL7550 Cybersecurity I

Students will learn to:

• Apply industry-leading data security and privacy compliance frameworks to realistic examples
• Conduct qualitative and quantitative cyber risk assessments and transfer cyber risks
• Prepare for and comply with legal requirements relating to data breaches and other legal process for digital information

Students will learn to:

• Apply the European Union's General Data Protection Regulation (GDPR) to different business practices and technologies
• Incorporate key principles of European human rights law into an analysis of data protection practices and policies
• Anticipate future directions in the evolution of European data protection and information privacy law

Students will learn to:

• Analyze the operations of banks and financial institutions to determine whether they are in compliance with the provisions of the Money Laundering Control Act, the Bank Secrecy Act, and associated regulations
• Identify best practices in the financial services and banking sectors in addressing concerns about financial crimes, including “know your customer” programs and associated reporting systems
• Identify red flags in banking and financial services accounts and transactions that necessitate further investigation of customers, with particular reference to politically exposed persons, correspondent banking, and trade finance transactions at the international and domestic levels

Students will learn to:

• Evaluate how complex privacy regulations apply to particular types of financial institutions and transactions
• Recognize triggers for the various disclosures, notices, and reports required by the major statutory regimes
• Asses potential legal liability stemming from privacy and security breaches and design appropriate responses

Students will learn to:

• Identify red flags in business activities that would require further assessment for compliance with anti-corruption laws
• Analyze company activities to determine whether they violate the U.S Foreign Corrupt Practices Act, the UK Bribery Act, or other laws
• Articulate the key elements of a global anti-corruption compliance program

Students will learn to:

• Assess governmental compliance rules and regulations
• Analyze existing case authority in implementing current and future compliance policies
• Formulate conceptual frameworks for future compliance strategies in corporate governance

Students will learn to:

• Identify the basic legal issues that arise in starting, operating, and terminating a business
• Evaluate the legal obligations of agents, partners, and corporate officers and directors
• Propose terms to be incorporated into articles, agreements, or bylaws to solve particular business or organizational problems

Students will learn to:

• Identify situations in which important employee protections — including antidiscrimination, leave, and wage and hour protections — may be implicated in employment decisions
• Analyze potential legal claims and defenses arising in an array of work-related circumstances
• Apply risk-management strategies to address or reduce potential legal risks

Students will learn to:

• Evaluate the current legal framework for consumer privacy protection in the United States
• Identify key challenges for individual consumers in controlling access to, and use of, their personal information
• Examine the effectiveness and enforceability of consumer privacy policies
• Contrast the advantages and disadvantages of “opt in” versus “opt out” models of privacy protection

Students will learn to:

• Identify key sources of law applicable to the Internet as a decentered, community-standards focused network system
• Assess risks to cybersecurity from mismanagement, crime, terrorism, and war
• Evaluate proposed changes in the law related to cybersecurity and assess their implications for the industry and civil society

Prerequisite: INDL7550 Cybersecurity I

Students will learn to:

• Apply industry-leading data security and privacy compliance frameworks to realistic examples
• Conduct qualitative and quantitative cyber risk assessments and transfer cyber risks
• Prepare for and comply with legal requirements relating to data breaches and other legal process for digital information

Students will learn to:

• Apply the European Union's General Data Protection Regulation (GDPR) to different business practices and technologies
• Incorporate key principles of European human rights law into an analysis of data protection practices and policies
• Anticipate future directions in the evolution of European data protection and information privacy law

Students will learn to:

• Evaluate how complex privacy regulations apply to particular types of financial institutions and transactions
• Recognize triggers for the various disclosures, notices, and reports required by the major statutory regimes
• Asses potential legal liability stemming from privacy and security breaches and design appropriate responses

Students will learn to:

• Evaluate and determine whether a given authorization, privacy policy or business associate agreement complies with HIPAA
• Identify and articulate the potential enforcement methods and outcomes and the requirements for breach notification
• Assess and critique the regulatory choices made under HIPAA

Students will learn to:

• Define the categories of laws that protect workplace privacy, and the limits inherent in their application to questions of employee privacy rights
• Advise employers about how to craft effective privacy policies and when, and how, to obtain effective consent from employees to monitoring
• Evaluate the approaches of courts and legislatures in different jurisdictions to creating an acceptable level of workplace privacy