New Faculty OrientationOffice of the General Counsel

Anne K. GarciaSenior Associate General Counsel

Executive Director of Billing and Research Compliance

New Faculty Orientation

Office of the General CounselProvides legal guidance and services

Saint Louis University provides coverage for:FacultyFellowsResidentsMedical StudentsOther Staff

New Faculty Orientation

Coverage is provided for all occurrences that happened during the course and scope of your employment with Saint Louis University.

NOT COVERED:If injuries result from acts or omissions while under

the influence of drugs or alcoholCriminal or intentional actsOutside the normal course and scope of your

employment

New Faculty Orientation

Failure to Cooperate with OGC or Defense Counsel

Insurance:University is self insured up to $2 millionExcess commercial insurance is provided up to

$25 million per year.

New Faculty Orientation

Reporting of IncidentsPlease report promptly (within 24-48 hours)Methods of Reporting

977-URPT (8778)Slucareincident.slu.edu

Username: INCIDENTPassword: SLUCARE1!

Call the OGC at 977-5767

New Faculty Orientation

Other Helpful TipsIf an attorney calls, please direct them to the OGC

at 977-5767. Do not speak with the attorney.If you receive a BHA or AG complaint direct it to

the OGCDirect any process servers to the OGCIf you are named in a lawsuit, OGC will appoint

defense counsel and will notify you of your assigned counsel.

New Faculty Orientation

Other Helpful Tips (Continued)Complete and Timely DocumentationLimit Email Communications (Discoverable)Please discuss patient care in the appropriate

settingNeed assistance handling a difficult issue/family

involve Risk Management

New Faculty Orientation

Questions???

Office of University Compliance

Physician Billing CompliancePrivacy/HIPAAResearch Compliance Export Controls

Billing Compliance

Routine audits of billing records EducationRepayments to CMS and insurance companiesSanction checks for HSC employees and vendors

Privacy/HIPAAEnsure SLU’s compliance with HIPAA privacy regulationsProvide HIPAA education to SLU workforceEstablish and maintain policies regarding privacyProvide incident response to issues of privacyAdvise staff and management regarding privacy mattersCollaborate with IT to address appropriate safeguarding

of informationPrivacy Officer: Ron Rawson, rawsonr@slu.edu; 977-5880

Research Compliance

Audits/Reviews of Research DivisionsIACUC, IRB, OEHS, etc.

Clinical Trial reviewsSunshine ActResearch misconduct investigationsEducation

Reporting

Saint Louis University Compliance HotlineAvailable and answered 24/7Caller / reporter may remain anonymousProtection provided

The Saint Louis University Office of University Compliance is committed to excellence in corporate integrity and responsibility. This commitment is realized through the integration of education, leadership, and service. Through collaboration the Department promotes the highest standards of ethical, moral, and lawful practices. These efforts areguided by the mission of Saint LouisUniversity and the Jesuit tradition.

http://www.slu.edu/general-counsel-home/compliance

Questions?

Export ControlsExport Controls

Michael Reeves

Export Control Officer

Michael Reeves

Export Control Officer

Export ControlsExport Controls

Federal Export Control regulations restrict the following exports:

• Tangible goods: technology, letters, software, or packages

• Communication: email and phone conversations

• International travel

Federal Export Control regulations restrict the following exports:

• Tangible goods: technology, letters, software, or packages

• Communication: email and phone conversations

• International travel

DefinitionsDefinitions

• “U.S. Person”-Any person who is a citizen of the United States, a lawful permanent resident alien of the United States, a refugee or someone here under amnesty.

• “Foreign National”- Any individual or organization that is not a U.S. person.

• “Technology Control Plan”-Plan used to manage Export Control restrictions during research project.

• “U.S. Person”-Any person who is a citizen of the United States, a lawful permanent resident alien of the United States, a refugee or someone here under amnesty.

• “Foreign National”- Any individual or organization that is not a U.S. person.

• “Technology Control Plan”-Plan used to manage Export Control restrictions during research project.

“Deemed Export”“Deemed Export”

• “Deemed Export”- Discussion with a “Foreign National” or providing them access to controlled research within the borders of the United States.

• “Deemed Export”- Discussion with a “Foreign National” or providing them access to controlled research within the borders of the United States.

Regulated by 3 federal agencies:Regulated by 3 federal agencies:

• Department of Commerce

• Department of State

• Department of the Treasury

• Department of Commerce

• Department of State

• Department of the Treasury

Department of CommerceDepartment of Commerce

• Export Administration Regulations (EAR)

• 15 CFR 730-774

• “Dual-use” items- commercial goods, services, and technologies that also have military or proliferation possibilities. (i.e. GPS, UAV)

• Maintain Commerce Control List

• Export Administration Regulations (EAR)

• 15 CFR 730-774

• “Dual-use” items- commercial goods, services, and technologies that also have military or proliferation possibilities. (i.e. GPS, UAV)

• Maintain Commerce Control List

Department of State Department of State

• International Traffic in Arms Regulations (ITAR)

• 22 CFR 120-130

• Defense items-products specifically designed for military applications (i.e. missiles)

• Maintain Munitions list

• Recently updated category XV

• “Defense Services”

• International Traffic in Arms Regulations (ITAR)

• 22 CFR 120-130

• Defense items-products specifically designed for military applications (i.e. missiles)

• Maintain Munitions list

• Recently updated category XV

• “Defense Services”

Department of the TreasuryDepartment of the Treasury

• Office of Foreign Assets Control (OFAC)

• 31 CFR 500-599

• Regulates countries, organizations, and individuals. Targets terrorists, drug traffickers, WMD proliferators, human rights violators, anti-boycott and narcotics (i.e. Marion, IL golf course, )

• Maintain sanction lists for the above groups

• Office of Foreign Assets Control (OFAC)

• 31 CFR 500-599

• Regulates countries, organizations, and individuals. Targets terrorists, drug traffickers, WMD proliferators, human rights violators, anti-boycott and narcotics (i.e. Marion, IL golf course, )

• Maintain sanction lists for the above groups

Export restricted and embargoed countriesExport restricted and embargoed countries

• All three federal agencies maintain lists of restricted and embargoed countries

• Comprehensive Sanctioned Countries T-5 (Cuba, Iran,, N. Korea, Syria, Sudan)

• Most countries have commodity or information exchange specially restricted (i.e. China, Russia)

• All three federal agencies maintain lists of restricted and embargoed countries

• Comprehensive Sanctioned Countries T-5 (Cuba, Iran,, N. Korea, Syria, Sudan)

• Most countries have commodity or information exchange specially restricted (i.e. China, Russia)

Fundamental Research ExclusionFundamental Research Exclusion

• Ordinarily published and shared broadly within the scientific community

• Generally accessible to the interested public in any form

• Applies only to information, not tangible goods

• Ordinarily published and shared broadly within the scientific community

• Generally accessible to the interested public in any form

• Applies only to information, not tangible goods

EducationalEducational

• General science, math and engineering commonly taught at schools and universities (ITAR)

• Information conveyed in courses listed in course catalogues and in their associated teaching labs of any academic institution (EAR)

• General science, math and engineering commonly taught at schools and universities (ITAR)

• Information conveyed in courses listed in course catalogues and in their associated teaching labs of any academic institution (EAR)

Bona Fide EmployeeBona Fide Employee

• Is a full-time, bona fide employee;

• Is not a national of certain countries;

• Has a permanent residence in the US while employed; and

• Is advised in writing not to share covered technical data with foreign nationals.

• Is a full-time, bona fide employee;

• Is not a national of certain countries;

• Has a permanent residence in the US while employed; and

• Is advised in writing not to share covered technical data with foreign nationals.

LicensesLicenses

Current process requires us to seek license for highest level of restriction;

• ITAR

• EAR

• OFAC-Travel to all T-5 and most D-1 countries

Current process requires us to seek license for highest level of restriction;

• ITAR

• EAR

• OFAC-Travel to all T-5 and most D-1 countries

Areas of Concern for SLU Areas of Concern for SLU

• Downloading software on a restricted computer• Providing technology/technical data via email, fax or

during a phone conversation or a meeting to a foreign national

• Provision of defense services to a foreign person; wherever the services take place

• Re-export • Shadowing into restricted spaces

• Downloading software on a restricted computer• Providing technology/technical data via email, fax or

during a phone conversation or a meeting to a foreign national

• Provision of defense services to a foreign person; wherever the services take place

• Re-export • Shadowing into restricted spaces

Travel Travel

• Traveling with SLU equipment

• Temporary Export Certificate

• Clean computer

• Traveling with personal technology

• All technology is on CCL

• No research on personal devices while traveling

• Traveling with SLU equipment

• Temporary Export Certificate

• Clean computer

• Traveling with personal technology

• All technology is on CCL

• No research on personal devices while traveling

Penalties for ViolationsPenalties for Violations• ITAR: Civil Penalties-Up to $500,000 fine

• ITAR: Criminal Penalties-Up to $1 million fine, up to 10 years in prison

• EAR: Civil Penalties-Up to $250,000 fine

• EAR: Criminal Penalties-Up to $1 million fine, 20 years in prison.

• OFAC: Civil Penalties-Up to $250,000 fine

• OFAC: Criminal Violations-Up to $1 million fine, 10 years in prison.

• ITAR: Civil Penalties-Up to $500,000 fine

• ITAR: Criminal Penalties-Up to $1 million fine, up to 10 years in prison

• EAR: Civil Penalties-Up to $250,000 fine

• EAR: Criminal Penalties-Up to $1 million fine, 20 years in prison.

• OFAC: Civil Penalties-Up to $250,000 fine

• OFAC: Criminal Violations-Up to $1 million fine, 10 years in prison.

Examples of ViolationsExamples of Violations

• Professor J. Reece Roth, University of Tennessee

• Guilty of 18 counts of conspiracy, fraud, and violating the Arms Export Control Act

• Sentenced to 48 months

• UT escaped fine because of cooperation and policy

• UM-Lowell- Failed to screen company- $100,000 fine.

•ITT-leading producer of night vision goggles -$100 million fine

•Boeing $4.2 million and $15 million fines

• Professor J. Reece Roth, University of Tennessee

• Guilty of 18 counts of conspiracy, fraud, and violating the Arms Export Control Act

• Sentenced to 48 months

• UT escaped fine because of cooperation and policy

• UM-Lowell- Failed to screen company- $100,000 fine.

•ITT-leading producer of night vision goggles -$100 million fine

•Boeing $4.2 million and $15 million fines

Contact informationContact information

• Michael Reeves, University Export Control Officer

mreeves8@slu.edu, 977-5880

• Michael Reeves, University Export Control Officer

mreeves8@slu.edu, 977-5880

Questions? Questions?