Download Records Retention Policy Directives

RECORD RETENTION AND eDISCOVERY
Massachusetts Biotechnology Council
Dawn M. Curry
December 16, 2008
Nutter McClennen & Fish LLP
World Trade Center West
155 Seaport Boulevard
Boston, Massachusetts 02210
Telephone 617.439.2000
www.nutter.com
Topics of Discussion
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The Benefits of Having a Record Retention Policy
Why Such a Policy is Particularly Important in Your
Industry
Why Now is the Time to Re-evaluate/Implement a Policy
Critical Record Retention Policy Directives
Retention Schedules
When Does the Duty to Preserve Arise
Litigation Holds
Other Steps to Take Upon Reasonable Anticipation of
Litigation
Collection, Reduction and Production of Documents
Use of Technology for Electronic Record Management
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Electronic Records Management Survey
(By Cohasset Associates):
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2007 Survey of 1600 records management professionals:
– 35% of respondents evaluated their records
management programs as "marginal" or "fair."
– 40% of organizations represented that they still do not
include electronic records in their retention schedules.
– 68% affirmed that their organization had "some" (38%),
"considerable" (20%) or "great" (10%) difficulty finding
and retrieving information from backup and archival
storage media in response to court-ordered discovery.
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Why Have A Records Retention Policy?
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Provides for the systematic review, retention and
destruction of records.
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Compliance with statutory and regulatory duties and
requirements.
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Manages information generated and received by the
Company.
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Reduces strain on computer and information systems, and
reduces storage expense.
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Reduces unnecessary expense during litigation.
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May help protect the Company in litigation.
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Why Is This Important For Companies In Your
Industry?
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Heavily regulated industry
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Companies have been generating more and more electronic
records.
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Documents in this industry are the most valuable assets.
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Original records today often include digital records with
electronic signatures that need to be preserved and
accessed over time.
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21 CFR Part 11
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21 CFR Part 11 changed the landscape
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Companies can choose to electronically submit various
documents: Biologics License Applications, New Drug
Applications and Abbreviated New Drug Applications;
IND Applications; related submissions; premarket
notification applications (510(k)) and Medwatch 3500A
forms for medical device adverse event reports.
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If a Company chooses to use records in electronic
format in place of paper format, Part 11 will apply.
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21 CFR 11.10(c) requires the protection of records to
enable their accurate and ready retrieval throughout the
records retention period.
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Why Take Action Now?
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Changes in the Fed. Rules of Civil Procedure
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Electronically stored information (“ESI”) must be
discussed early on in the litigation at the Rule 26
conference.
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Companies must adopt a new approach to litigation
preparedness – including record retention policies.
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Fed. R. Civ. P. 37(e) - creates a safe harbor from
sanctions for spoliation if the ESI is lost in the regular
course of business. The rule states that “[a]bsent
extraordinary circumstances, a Court may not impose
sanctions under these rules on a party for failing to
provide ESI lost as a result of the routine, good-faith
operation of an electronic information system.”
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Why Take Action Now? (cont’d)
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The Pharmaceutical and Medical Device Manufacturer
Code of Conduct. 105 CMR 970.000 (proposed regs)
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New regs will require disclosure of financial interactions
between the industry (pharmaceutical and medical
device companies) and certain health care providers.
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Companies must report the value, nature, purpose and
recipient of any fee, payment or subsidy over $50 for a
company’s sales and marketing activities.
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The first disclosure report would be due July 1, 2010 for
the time period July 1, 2009 through December 31,
2009. In future years, the disclosure would cover the
entire previous calendar year.
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Public hearings - Jan. 9 and Jan. 12
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Records Retention Policy Directives
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The policy must be established based on sound
business practices.
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All records, including ESI, must be covered by the
program.
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The policy should address the proper handling of
confidential records.
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You must establish records retention schedules that
comply with the laws, regulatory requirements and
business/scientific needs.
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Records Retention Policy Directives (cont’d)
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The policy should provide for appropriate archival media
to ensure preservation for the duration of the retention
periods.
Policy should also address appropriate data security
requirements and proper disposal of records. New
statutes/regs require anyone holding personal info on a
resident of MA to follow certain procedures – see G.L. c.
93H and 93I and 201 CMR 17.00.
Upon “reasonable anticipation of litigation” you must
suspend the destruction of records to the extent
necessary to preserve relevant ESI. Instruct employees
to notify legal (or an appointed person at the Company)
about potential litigation/investigations.
At least one person in the Company should be
responsible for auditing/managing the program. (to
ensure that it is up to date and that destruction proceeds
in an orderly manner)
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Retention Schedules
There are general categories of documents that must be
maintained for specific periods of time:
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E.g., tax records pursuant to IRS regulations, and
employment records pursuant to Fair Labor Standards
Act (FLSA), Occupational Safety and Health Act
(OSHA), and Employment Retirement Income Security
Act (ERISA)
Then there are industry specific records and regulatory retention
periods:
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E.g., records required to be maintained pursuant to FDA
regulations and HIPAA
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Industry Specific Retention Schedules
Applicable to Manufacturers
of Drugs, Biologics and Devices
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Financial Records of Clinical Investigators
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21 CFR 54.6
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Who: an applicant who submits a marketing application
containing clinical studies to the FDA
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What: information pertaining to the financial interests of the
clinical investigators who conducted the studies who are not
employees of the applicant
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How long: for 2 years after the date of approval of the
application
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Institutional Review Board Records
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21 CFR 56.115; 45 CFR 46.115.
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Who: an institution, or where appropriate an IRB
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What: adequate documentation of IRB activities
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How long: for at least 3 years after completion of the
research
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Dissemination of Info Re: Unapproved/ New
Uses for Marketed Drugs, Biologics and Devices
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21 CFR 99.501
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Who: a manufacturer disseminating such information
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What: records sufficient to allow the manufacturer to take
corrective action as required by the FDA, including a copy of
all information, lists, records, and reports required or
disseminated under this part
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How long: for 3 years after it has ceased dissemination of
such information
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Privacy of Individually Identifiable Health
Information
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45 CFR 164.530
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Who: covered entities
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What: documentation related to policies and procedures
implemented with respect to protected health information to
comply with HIPAA
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How long: for 6 years from the date of creation OR the date
when it was last in effect, whichever is later
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Industry Specific Retention Schedules
Specific to Drugs
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Prescription Drug Marketing Act Records
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21 CFR 203.60
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Who: any person required to create or maintain reports, lists,
or other records under the PDMA
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What: these reports, lists or records, including records
relating to the distribution of drug samples
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How long: for at least 3 years after the date of their creation
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Batch Records
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21 CFR 211.180
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What: production, control, or distribution records associated
with a batch of a drug product
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How long: for at least 1 year after the expiration of the batch
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Exception: for certain OTC drug products lacking expiration
dating because they are exempt, the retention period is 3
years after distribution of the batch
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Batch Records
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21 CFR 211.180
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What: records for all components, drug product containers,
closures, and labeling
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How long: for at least 1 year after the expiration date
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Exception: for certain OTC drug products lacking expiration
dating because they are exempt, the retention period is 3
years after distribution of the last lot of drug product
incorporating the component or using the container, closure or
labeling
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Investigational New Drug Applications:
Sponsor Record Retention
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21 CFR 312.57
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Who: sponsors
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What: adequate records showing the receipt, shipment, or
other disposition of the investigational drug, including the
name of the investigator to whom the drug is shipped, and the
date, quantity, and batch or code mark of each shipment
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How long: for 2 years after a marketing application is
approved for the drug; or, if not approved, until 2 years after
shipment and delivery of the drug for investigational use is
discontinued and the FDA has been so notified
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Investigational New Drug Applications:
Investigator Record Retention
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21 CFR 312.62
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Who: an investigator
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What: adequate records of the disposition of the drug,
including dates, quantity, and use by subjects
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How long: for a period of 2 years following the date a
marketing application is approved for the drug for the
indication for which it is being investigated; or, if no application
is filed or if the application is not approved, until 2 years after
the investigation is discontinued and the FDA has been
notified
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Adverse Experiences on Marketed Prescription
Drugs Without Approved New Drug Applications
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21 CFR 310.305
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Who: manufacturers, packers and distributors of these drugs
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What: records and reports to the FDA of all serious,
unexpected adverse drug experiences associated with the
use of their drug products
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How long: for a period of 10 years, including raw data and
any correspondence relating to the adverse drug experiences
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Postmarketing Reporting of Adverse Drug
Experiences
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21 CFR 314.80
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Who: applicants having approved applications
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What: review and report to the FDA all adverse drug
experience information obtained or otherwise received by the
applicant from any source, foreign or domestic, including info
derived from commercial marketing experience,
postmarketing clinical investigations, reports in scientific
literature, and unpublished scientific papers
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How long: for a period of 10 years
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Industry Specific Retention Schedules
Specific to Biologics
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Postmarketing Reporting of Adverse Drug
Experiences
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21 CFR 600.80
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Who: any person having a biologics license
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What: review and report to the FDA all adverse experience
information pertaining to its product obtained or otherwise
received from any source, foreign or domestic, including
information derived from commercial marketing experience,
postmarketing clinical investigations, reports in scientific
literature, and unpublished scientific papers
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How long: for a period of 10 years
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Blood and Blood Components
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21 CFR 606.160
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What: records regarding the performance of each significant
step in the collection, processing, compatibility testing,
storage and distribution of each unit of blood and blood
components so that all steps can be clearly traced.
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How long: no less than 10 years after the records of
processing have been completed (or 6 months after the latest
expiration date for the individual product, whichever is later).
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Industry Specific Retention Schedules
Specific to Medical Devices
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Medical Devices – cGMP records
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21 CFR 820.180
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What: all Good Manufacturing Records required to be kept
under section 820, including device master records and
device history records
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How long: shall be retained for a period of time equivalent to
the design and expected life of the device, but in no case less
than 2 years from the date of release for commercial
distribution by the manufacturer.
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Medical Device Reporting
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21 CFR 803.18
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Who: a user facility, importer, or manufacturer
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What: MDR event files relating to adverse events
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How long:
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A user facility: for a period of 2 years from the date of
the adverse event.
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A manufacturer or importer: for a period of 2 years from
the date of the event or a period of time equivalent to the
expected life of the device, whichever is greater
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Investigational Device Records : Investigator
Record Retention
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21 CFR 812.140
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Who: a participating investigator
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What: records relating to the investigator’s participation in an
investigation, inc. correspondence with another investigator,
an IRB, the sponsor, a monitor, or FDA; records of receipt,
use or disposition of a device; records of each subject’s case
history and exposure to the device; and the protocol, with
docs showing dates of and reasons for each deviation from
the protocol.
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How long: during the investigation and for 2 years after the
latter of either the date on which the investigation is
terminated or completed OR the date that the records are no
longer required to support a PMA or a notice of completion of
a product development protocol
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Investigational Device Records:
Sponsor Record Retention
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21 CFR 812.140
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Who: a sponsor
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What: records relating to an investigation, including
correspondence with another sponsor, a monitor, an
investigator, an IRB, or FDA; records of shipment and
disposition; and signed investigator agreements.
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How long: same as investigator retained records
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When Does the Duty to Preserve Arise?
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Duty to preserve arises upon “reasonable anticipation” of
litigation or a government investigation
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“Reasonable anticipation of litigation arises when an
organization is on notice of a credible threat it will
become involved in litigation or anticipates taking action
to initiate litigation” Sedona Commentary on Legal
Holds, Guideline No. 1.
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“The determination of whether litigation is reasonably
anticipated should be based on good faith,
reasonableness, a reasonable investigation and an
evaluation of the relevant facts and circumstances”
Sedona Commentary on Legal Holds, Guideline No. 4.
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When Does the Duty to Preserve Arise?
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Plaintiff’s side:
– Decision to send cease and desist letter or the
decision to file a lawsuit
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Defendant’s side:
– Credible information that you are the target of legal
action
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Fact intensive analysis.
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Duty to preserve extends only to relevant
information (what, who, when, where?)
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Analyze claims/defenses to identify what are the relevant
categories of information
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Identify who are the key custodians involved
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Determine when are the relevant time periods
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Identify where the relevant data is likely being stored
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This will help you to determine: (1) which parts of your
records retention policy need to be suspended to
preserve all relevant data; and (2) who needs to be
notified regarding the duty to preserve
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Litigation Hold Considerations
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Depending on the circumstances, send written litigation
hold to persons likely to have relevant data.
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Form, content, and distribution of a litigation hold will
vary depending on the case and client circumstances.
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Litigation hold should be periodically re-issued.
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Companies should regularly monitor a litigation hold to
ensure compliance.
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Other Steps to Take Upon Reasonable
Anticipation of Litigation
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Counsel should communicate directly with key
employees to make sure they understand their
preservation obligations.
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Companies should document the steps taken to
preserve information.
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Collection of Electronic Documents
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Determine the scope of the ESI needed to fairly address
the issues in the case.
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Avoid unreasonable overbreadth, burden and cost.
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Only need to produce relevant ESI that is reasonably
accessible.
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Determine if metadata needs to be produced.
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Collection of Electronic Documents (cont’d)
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Establish a procedure for collection of ESI:
• Manual collection: items are copied or transmitted by
the end-user.
• Automated collection: uses computerized processes
to collect data.
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Establish and maintain chain of custody.
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Vendors
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Discuss whether an outside vendor should be hired to
assist in the preservation, collection, review and/or
production of your data.
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Vendors offer a variety of software and services to assist
with the electronic discovery process that can
substantially reduce overall costs.
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Symantec offers a technology solution which works to
combine retention needs with discovery needs.
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Reduction of Documents
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Examples of ways to reduce the volume of ESI
reviewed:
• De-duplication tools; simple keyword searches;
boolean searches; conceptual searching
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Consider sampling techniques.
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No perfect search – standard is reasonableness and
good faith.
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Consider entering into an agreement with opposing
counsel to stipulate to the locations to be searched, the
individuals whose records are at issue, and the search
and retrieval methods to be used.
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Production of Documents
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Try to also come to an agreement with opposing counsel
regarding the form(s) of production.
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Absent agreement of the parties, a responding party
must produce ESI in the form in which it is ordinarily
maintained or in a reasonably usable form.
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The parties can agree to produce different types of ESI
in different forms.
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Different formats have advantages and disadvantages:
Native vs. TIFF
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QUESTIONS?
Dawn M. Curry, Esq.
Nutter, McClennen & Fish, LLP
617.439.2286
[email protected]
www.nutter.com
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