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Graduate Certificate Programs

 

Division of Online Learning

lawonline@shu.edu | 973-642-8747 or 973-761-9000 ext. 8747

Seton Hall Law offers four online law programs designed specifically for professionals who work in highly regulated fields. The programs are delivered online and can be completed in 24 weeks. Each program is divided into three eight-week segments. The four Online Graduate Certificate program choices are:

The online format offers flexibility for individuals who have commitments that make it difficult for them to attend classes on campus. The online certificate courses are taught by the same instructors who teach at the Seton Hall Law campus.

Interested students may enroll in individual courses to obtain CLE or CEU credit; however, a certificate will not be awarded until three courses have been completed. Three courses in one area satisfy the certificate requirement.

Certificate in Pharmaceutical & Medical Device Law & Compliance | 24 Weeks

This program is ideal if you work in compliance, legal, regulatory and medical affairs, sales, marketing, grants, and related areas in the pharmaceutical and medical device industries. A Certificate in Pharmaceutical & Medical Device Law & Compliance can be completed in 24 weeks and will be awarded upon completion of any three courses listed below. Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

Number Name Credit Offering

HLTH9529

Biotechnology and the Law

This course examines a variety of legal, policy, scientific, social, and ethical issues in the realm of biotechnology. Topics covered include:

  1. Foundational technologies, such as recombinant DNA technology

  2. Current applications, including nanobiotechnology and synthetic biology

  3. Human subjects research and institutional review of clinical trials

  4. Regulatory oversight by federal agencies

  5. Academic-industry relationships

  6. Data privacy and security issues

  7. Protection of intellectual property

3

online

HLTH7685

Clinical Research and the Law: Compliance Issues for Research Sponsors

This course examines the responsibilities of life science companies and other entities responsible for the initiation, management, and/or financing of clinical trials in the United States, the European Union, and elsewhere in the world. Topics covered include good clinical practice (GCP) compliance, clinical trial agreements, clinical trial registration and results reporting, access to clinical trial data, managing conflicts of interest, reimbursement issues, and the implications of anti-bribery laws and U.S. fraud and abuse laws for clinical research.

3

online

HLTH7680

Clinical Research and the Law: Ethical and Regulatory Issues in Designing Clinical Trials

This course immerses students in the laws, regulations, and ethical guidelines applicable to designing clinical research in the United States, the European Union, and elsewhere in the world. Topics covered include an overview of the regulatory framework in the US, the EU, and other regions; the role of international ethical guidelines; ethical and regulatory considerations in choosing a study methodology; informed consent; confidentiality and data protection; the inclusion of women and minorities in clinical research; pediatric research; and post-trial obligations.

3

online

HLTH7590

Compliance Issues in the Life Sciences - Advertising, Promotion and Transparency

This course provides an overview of the laws, regulations, guidances and enforcement actions related to the advertising and promotion of prescription drugs and medical devices. Topics covered include:

  1. Direct-to-consumer advertising

  2. Off-label promotion

  3. Scientific and educational exchange

  4. Social Media

  5. Constitutional limitations on government regulation of commercial speech

  6. Transparency and disclosure requirements

3

online

HLTH7580

Compliance Issues in the Life Sciences - Fraud and Corruption

This course examines life science companies’ obligations under laws designed to detect and respond to bribery, fraud, waste, and abuse. Topics covered include:

  1. The Anti-Kickback Statute

  2. The False Claims Act

  3. The Foreign Corrupt Practices Act and other international anti-bribery legislation

  4. The Racketeer Influenced and Corrupt Organizations Act (RICO)

  5. Enforcement mechanisms

  6. Corporate compliance programs

3

online

INDL7550

Cybersecurity and Privacy: Law, Policy, Compliance

This course examines the legal, policy, and compliance challenges raised by efforts to protect the Internet and other forms of networked computer systems from attack by hackers, organized criminal groups, terrorists, and others. Topics include:

  1. Threats to cybersecurity

  2. Domestic and international Internet governance

  3. The Computer Fraud and Abuse Act

  4. U.S. and European Union privacy law and personal data protection

  5. War, international terrorism, and U.S. surveillance law

  6. Private information infrastructure and the law of emergencies

  7. Emerging compliance frameworks for cybersecurity

3

online

CORP7180

EU Data Protection and Privacy Law

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include the privacy jurisprudence of the European Court of Human Rights, the EU Data Protection Directive and the General Data Protection Regulation, data protection authorities, international data transfers, and cybersecurity in Europe.

3

online

HLTH7560

FDA Regulation and Liability

This course explores the FDA's extensive regulation of the pharmaceutical and medical device industries, as well the relationship between FDA regulation and state-law tort liability. Topics covered include:

  1. The drug and biologic approval processes

  2. The medical device approval and clearance process

  3. Postmarket obligations and pharmacovigilance

  4. Products liability and federal preemption

  5. FDA enforcement

3

online

CORP7160

Global Corruption: Regulation, Compliance, and Enforcement

This course introduces students to the theory and practice of global anti-corruption compliance. Topics covered include the definition, identification and measurement of corruption; the OECD Convention on Combatting Bribery of Foreign Public Officials; the U.S. Foreign Corrupt Practices Act; the UK Bribery Act; anti-corruption laws in other countries; investigation, enforcement and resolution of corruption activities; jurisdiction, corporate liability and individual responsibility; and anti-corruption compliance programs and international organizational responses.

3

online

HLTH7504

HIPAA Privacy and Security

This course explores the federal regulatory scheme designed to protect the privacy and security of health information. Topics covered include:

  1. Entities and information to which HIPAA applies

  2. When consent is required for the use and disclosure of health information

  3. Types of health information requiring heightened protection

  4. Use of health information for research and marketing

  5. Security measures required to protect digitized health information

  6. Individuals’ right to access their health information

  7. Business associate agreements

  8. HIPAA compliance and enforcement

3

online

 

Certificate in Health & Hospital Law | 24 Weeks

This program is ideal if you are a lawyer transitioning to the healthcare industry. Hospital administrators and compliance officers, physicians, nurses, and other healthcare professionals, state and federal regulators, and patient advocates also benefit from the material. The graduate certificate in Health and Hospital Law is designed for professionals seeking to enhance their knowledge of legal, regulatory, and ethical issues related to the delivery of healthcare. A Certificate in Health & Hospital Law can be completed in 24 weeks and will be awarded upon completion of any three courses listed below. Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

Number Name Credit Offering

HLTH7524

Children's Health and the Law

This course examines the law governing medical treatment of minors, with an emphasis on the tension between parental authority, the child’s needs and wishes, the duty of medical professionals to provide adequate care, and the state’s interest in protecting the child from harm. Topics covered include:

  1. Religious objections to treatment

  2. Mental health and substance abuse treatment

  3. Reproductive healthcare

  4. The withholding or withdrawal of life-sustaining treatment

  5. Medical neglect and medical child abuse

  6. Public health and bioethical issues affecting children

3

online

HLTH7685

Clinical Research and the Law: Compliance Issues for Research Sponsors

This course examines the responsibilities of life science companies and other entities responsible for the initiation, management, and/or financing of clinical trials in the United States, the European Union, and elsewhere in the world. Topics covered include good clinical practice (GCP) compliance, clinical trial agreements, clinical trial registration and results reporting, access to clinical trial data, managing conflicts of interest, reimbursement issues, and the implications of anti-bribery laws and U.S. fraud and abuse laws for clinical research.

3

online

HLTH7680

Clinical Research and the Law: Ethical and Regulatory Issues in Designing Clinical Trials

This course immerses students in the laws, regulations, and ethical guidelines applicable to designing clinical research in the United States, the European Union, and elsewhere in the world. Topics covered include an overview of the regulatory framework in the US, the EU, and other regions; the role of international ethical guidelines; ethical and regulatory considerations in choosing a study methodology; informed consent; confidentiality and data protection; the inclusion of women and minorities in clinical research; pediatric research; and post-trial obligations.

3

online

HLTH7670

Compliance Issues for Healthcare Providers

This course introduces students to the primary areas of law that impose compliance obligations on healthcare providers. Topics covered include:

  1. Nonprofit corporation law

  2. Laws governing state and federal tax exemptions

  3. Federal fraud and abuse laws (including the Anti-Kickback Statute, the False Claims Act and the Stark Laws)

  4. Patient safety and quality

  5. Peer review and credentialing processes

  6. Medical error and safety programs

3

online

INDL7550

Cybersecurity and Privacy: Law, Policy, Compliance

This course examines the legal, policy, and compliance challenges raised by efforts to protect the Internet and other forms of networked computer systems from attack by hackers, organized criminal groups, terrorists, and others. Topics include:

  1. Threats to cybersecurity

  2. Domestic and international Internet governance

  3. The Computer Fraud and Abuse Act

  4. U.S. and European Union privacy law and personal data protection

  5. War, international terrorism, and U.S. surveillance law

  6. Private information infrastructure and the law of emergencies

  7. Emerging compliance frameworks for cybersecurity

3

online

CORP7180

EU Data Protection and Privacy Law

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include the privacy jurisprudence of the European Court of Human Rights, the EU Data Protection Directive and the General Data Protection Regulation, data protection authorities, international data transfers, and cybersecurity in Europe.

3

online

CORP7160

Global Corruption: Regulation, Compliance, and Enforcement

This course introduces students to the theory and practice of global anti-corruption compliance. Topics covered include the definition, identification and measurement of corruption; the OECD Convention on Combatting Bribery of Foreign Public Officials; the U.S. Foreign Corrupt Practices Act; the UK Bribery Act; anti-corruption laws in other countries; investigation, enforcement and resolution of corruption activities; jurisdiction, corporate liability and individual responsibility; and anti-corruption compliance programs and international organizational responses.

3

online

HLTH7504

HIPAA Privacy and Security

This course explores the federal regulatory scheme designed to protect the privacy and security of health information. Topics covered include:

  1. Entities and information to which HIPAA applies

  2. When consent is required for the use and disclosure of health information

  3. Types of health information requiring heightened protection

  4. Use of health information for research and marketing

  5. Security measures required to protect digitized health information

  6. Individuals’ right to access their health information

  7. Business associate agreements

  8. HIPAA compliance and enforcement

3

online

HLTH9509

Law of Death and Dying, The

This course explores legal, ethical and public policy issues related to end-of-life medical care. Topics covered include:

  1. Cost of end-of-life care
  2. Supreme Court end-of-life jurisprudence
  3. Advance directives and POLST
  4. Minimally conscious state
  5. Challenges at the beginning of life
  6. Physician-assisted suicide

3

HLTH7690

Stark Law and Compliance

This course provides an opportunity to explore, in-depth, the federal physician self-referral prohibition, known as the Stark Law. Topics covered include:

  1. Key elements of the Stark Law
  2. Regulatory exceptions to the Stark Law
  3. Identification of non-compliance
  4. Implications of Stark Law violations
  5. Mitigating risk of legal exposure under Stark
  6. Structuring compliant physician relationships

3

online

HLTH7660

The Law of Patient Care

This course provides an overview of key legal, ethical, and regulatory issues related to the provision of medical care. Topics covered include:

  1. The formation and termination of the provider-patient relationship

  2. The Emergency Medical Treatment and Active Labor Act (EMTALA)

  3. Medical malpractice

  4. Informed consent

  5. Medical confidentiality (including HIPAA compliance)

  6. Treatment decisions for patients who lack decision-making capacity

  7. Treatment decisions for children and adolescents

  8. Mental health treatment

3

online

 

Certificate in Intellectual Property Law | 24 Weeks

Protecting brands, inventions, and original works is essential in almost any industry. Our intellectual property online law courses provide an intensive exposure to the patent rights, trademark, trade secrets, and copyright protection laws. Entrepreneurs will find the information covered beneficial. A Certificate in Intellectual Property Law can be completed in 24 weeks and will be awarded upon completion of three courses. Two of the three courses must be Copyright Law, Patent & Trade Secret Law, or Trademark & Unfair Competition Law.  Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

Number Name Credit Offering

HLTH9529

Biotechnology and the Law

This course examines a variety of legal, policy, scientific, social, and ethical issues in the realm of biotechnology. Topics covered include:

  1. Foundational technologies, such as recombinant DNA technology

  2. Current applications, including nanobiotechnology and synthetic biology

  3. Human subjects research and institutional review of clinical trials

  4. Regulatory oversight by federal agencies

  5. Academic-industry relationships

  6. Data privacy and security issues

  7. Protection of intellectual property

3

online

INDL8301

Copyright Law

This course introduces students to the basic concepts and doctrines of copyright law. Topics covered include:

  1. Foundational principles of copyright law

  2. Copyright in special issues, such as software, architecture, and databases

  3. Derivative works, work for hire, and joint authorship

  4. The doctrine of fair use

  5. Copyright issues raised by new technologies that facilitate copying

  6. Digital works and information technologies

3

online

INDL7550

Cybersecurity and Privacy: Law, Policy, Compliance

This course examines the legal, policy, and compliance challenges raised by efforts to protect the Internet and other forms of networked computer systems from attack by hackers, organized criminal groups, terrorists, and others. Topics include:

  1. Threats to cybersecurity

  2. Domestic and international Internet governance

  3. The Computer Fraud and Abuse Act

  4. U.S. and European Union privacy law and personal data protection

  5. War, international terrorism, and U.S. surveillance law

  6. Private information infrastructure and the law of emergencies

  7. Emerging compliance frameworks for cybersecurity

3

online

CORP7180

EU Data Protection and Privacy Law

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include the privacy jurisprudence of the European Court of Human Rights, the EU Data Protection Directive and the General Data Protection Regulation, data protection authorities, international data transfers, and cybersecurity in Europe.

3

online

HLTH7504

HIPAA Privacy and Security

This course explores the federal regulatory scheme designed to protect the privacy and security of health information. Topics covered include:

  1. Entities and information to which HIPAA applies

  2. When consent is required for the use and disclosure of health information

  3. Types of health information requiring heightened protection

  4. Use of health information for research and marketing

  5. Security measures required to protect digitized health information

  6. Individuals’ right to access their health information

  7. Business associate agreements

  8. HIPAA compliance and enforcement

3

online

INDL7500

Patent and Trade Secret Law

This course provides an overview of the basic doctrines of patent law, as well as related rights such as trade secret law and drug law exclusivity under the Hatch-Waxman Act. Topics covered include:

  1. Standards and procedures for obtaining patent protection

  2. Patent infringement litigation

  3. The relationship between patent protection and trade secret law

  4. The role of patent law and litigation in the pharmaceutical industry

3

online

INDL8302

Trademark and Unfair Competition

This course explores common law and statutory protection of ideas, trade secrets, and trademarks. Topics covered include:

  1. Acquisition and loss of trademark rights

  2. Registration and licensing

  3. Problems of infringement, dilution, and misappropriation of trademarks

  4. Fair use and Internet use of trademarks and related remedies

3

online

 

Certificate in Financial Services Compliance | 24 Weeks

Expand your understanding of the law that governs financial institutions and position yourself to enhance the compliance efforts at your company. A Certificate in Financial Services Compliance can be completed in 24 weeks and will be awarded upon completion of three courses. At least one of the three courses must be Governance, Compliance, Enforcement and Risk Management, or Securities Regulation and Compliance. Note* - Securities Regulation and Compliance is a prerequisite to Regulating Broker-Dealers and Regulating Funds and Investment Advisors. Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

Number Name Credit Offering

INDL7550

Cybersecurity and Privacy: Law, Policy, Compliance

This course examines the legal, policy, and compliance challenges raised by efforts to protect the Internet and other forms of networked computer systems from attack by hackers, organized criminal groups, terrorists, and others. Topics include:

  1. Threats to cybersecurity

  2. Domestic and international Internet governance

  3. The Computer Fraud and Abuse Act

  4. U.S. and European Union privacy law and personal data protection

  5. War, international terrorism, and U.S. surveillance law

  6. Private information infrastructure and the law of emergencies

  7. Emerging compliance frameworks for cybersecurity

3

online

CORP7180

EU Data Protection and Privacy Law

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include the privacy jurisprudence of the European Court of Human Rights, the EU Data Protection Directive and the General Data Protection Regulation, data protection authorities, international data transfers, and cybersecurity in Europe.

3

online

CORP8160

Financial Crimes Compliance

3

online

CORP7160

Global Corruption: Regulation, Compliance, and Enforcement

This course introduces students to the theory and practice of global anti-corruption compliance. Topics covered include the definition, identification and measurement of corruption; the OECD Convention on Combatting Bribery of Foreign Public Officials; the U.S. Foreign Corrupt Practices Act; the UK Bribery Act; anti-corruption laws in other countries; investigation, enforcement and resolution of corruption activities; jurisdiction, corporate liability and individual responsibility; and anti-corruption compliance programs and international organizational responses.

3

online

CORP7144

Governance, Compliance, Enforcement and Risk Management

This course explores corporate governance metrics for complying with federal and state regulatory frameworks, including internal corporate compliance protocols used to fulfill the company’s mission and to minimize risk in the management of the corporation. Topics covered include:

  1. Corporate governance internal protocols

  2. Relationship dynamics between corporate fiduciaries and stakeholders

  3. Development of compliance and risk management policies and procedures

  4. Governmental regulatory compliance frameworks

  5. Attorney’s role in compliance programs

3

online

CORP8165

Introduction to Corporate Finance

This corporate finance course explores the key financial instruments used by corporations, and the legal rules that govern those instruments. Topics covered include:

  1. Capital structure

  2. Financial instruments

  3. Mergers & Acquisitions

  4. Financial Distress

3

online

CORP8170

Regulating Broker-Dealers

This course explores the roles and duties of brokers and dealers, the legal rules that govern these investment professionals, and the regulatory authorities that create and enforce these rules.  Topics covered include a general overview of the financial markets regulatory framework; the economic realities that create legal obligations under federal securities regulations and self-regulatory organizations' rules; supervision of broker-dealer financial distress, including protection of customer funds and liability for customer losses.

3

online

CORP8180

Regulating Funds and Investment Advisors

This course examines mutual funds (investment companies) and other related entities like hedge funds and private equity funds. Topics covered include:

  1. Investment Company Act of 1940

  2. Investment Advisers Act Of 1940

  3. Regulation of swaps and other derivatives under Dodd-Frank

  4. Role of the CFTC in regulating this market

  5. Relationship between funds and their broker-dealers

3

online

CORP7170

Securities Regulation and Compliance

This course focuses on mandatory affirmative disclosure requirements under the Securities Act of 1933 and the Securities Exchange Act of 1934, triggered by the public offering of securities and by their trading in public markets. Topics covered include:

  1. Federal regulation of the offer and sale of securities under the Securities Act of 1933

  2. Exemptions from federal registration

  3. Reporting obligations of public companies under the Securities Exchange Act of 1934

  4. Sanctions and civil damage liability for violating these requirements

3

online

 

Certificate in Privacy Law and Cyber Security | 24 Weeks

Explore complex privacy rules and current laws and practices that impact privacy rights. A Certificate in Privacy Law & Cyber Security can be completed in 24 weeks and will be awarded upon completion of three courses. Each course takes eight weeks to complete, and you may take them in any order you choose.

The courses offered are:

Number Name Credit Offering

INDL7306

Consumer Data Privacy Law

This course examines the complicated and porous scheme of legal privacy protections governing online and offline individual consumer information in the United States. The course will examine topics including:

  1. The role of privacy policies
  2. The Federal Trade Commission’s (FTC) enforcement of privacy violations
  3. Electronic Communications Privacy Act (ECPA) and the Computer Fraud and Abuse Act (CFAA)
  4. Protections for children’s information under the Children ‘s Online Privacy Protection Act (COPAA)
  5. Statutes providing protections against marketing calls and spam
  6. The role of tort lawsuits for individual consumer privacy violations

3

online

INDL7550

Cybersecurity and Privacy: Law, Policy, Compliance

This course examines the legal, policy, and compliance challenges raised by efforts to protect the Internet and other forms of networked computer systems from attack by hackers, organized criminal groups, terrorists, and others. Topics include:

  1. Threats to cybersecurity

  2. Domestic and international Internet governance

  3. The Computer Fraud and Abuse Act

  4. U.S. and European Union privacy law and personal data protection

  5. War, international terrorism, and U.S. surveillance law

  6. Private information infrastructure and the law of emergencies

  7. Emerging compliance frameworks for cybersecurity

3

online

CORP7180

EU Data Protection and Privacy Law

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include the privacy jurisprudence of the European Court of Human Rights, the EU Data Protection Directive and the General Data Protection Regulation, data protection authorities, international data transfers, and cybersecurity in Europe.

3

online

CORP7185

Financial Privacy Law

This course explores the federal, state and judicial scheme designed to protect the privacy and security of financial information. Topics covered include:

  1. Regulation of sharing consumer information by financial institutes under the Gramm-Leach Bliley Act.
  2. Regulation of credit reporting agencies under the Fair Credit Reporting Act (FCRA).
  3. Identity theft and businesses’ responsibilities under the Federal Trade Commission’s (FTC) Red Flag Rules.
  4. Protections of individual financial information against the government under the Fourth Amendment and the Right to Financial Privacy Act (RFPA).
  5. State financial privacy law
  6. Breach Notification and Financial Privacy

3

online

HLTH7504

HIPAA Privacy and Security

This course explores the federal regulatory scheme designed to protect the privacy and security of health information. Topics covered include:

  1. Entities and information to which HIPAA applies

  2. When consent is required for the use and disclosure of health information

  3. Types of health information requiring heightened protection

  4. Use of health information for research and marketing

  5. Security measures required to protect digitized health information

  6. Individuals’ right to access their health information

  7. Business associate agreements

  8. HIPAA compliance and enforcement

3

online

LABR7600

Workplace Privacy Law

This course examines the modern realities of privacy in the workplace, covering the kinds of personal information an employer may want to learn about an employee, or prospective employee, as well as the kinds of monitoring an employer may conduct in relation to employees: email monitoring, social media monitoring, drug testing, and even DNA testing. Attention is paid to the use of new technologies, including digital technologies and biotechnological advances, that enable new forms of incursion into employee privacy. The course surveys the current patchwork of American laws that apply to workplace privacy, including principles of constitutional law, tort law, contract law and federal statutes that protect employee privacy. Some comparison is made with laws in other countries, specifically countries of the European Union, as these laws are increasingly relevant to organizations that operate across national borders.

3

online


 


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