Download - Oliver Johnson, Esq. Chief Privacy Officer Merck & Co., Inc

1

The Impact of HIPAA on U.S. Biomedical Research

Presented To The:

Dartmouth Hitchcock Medical CenterRegional IRB Meeting

Hanover, NH March 24, 2003

Oliver Johnson, Esq.

Chief Privacy Officer

Merck & Co., Inc.

2

Overview

• HIPAA Basics– What is HIPAA?

– Who is covered?

– What is permitted?

• Recent Changes to HIPAA• Impact of HIPAA on Biomedical Research• Impact Management Strategies

Merck Privacy Office

3

“Biomedical Research”

• Clinical Research• Epidemiologic Research• Outcomes Research


4

What is HIPAA?

• The Health Insurance Portability and Accountability Act of 1996; and

• Three sets of regulations issued by the Clinton Department of Health and Human Services in 2000:– Privacy Regulations - April 14, 2003 Compliance Deadline

– Transaction Standards - October 16,2002 Compliance Deadline

– Security Regulations - Pending

• Privacy rule revised by the Bush Department of Health and Human Services on August 14, 2002

RED = August 14, 2002 DeletionsBLUE = August 14, 2002 AdditionsGREEN = August 14, 2002 Reorganization


5

Who is covered?

• HIPAA “Covered Entities”– Health Care Providers that transmit health data

electronically in connection with 1 or more of 8 “HIPAA Transactions”

Physicians Hospitals ClinicsGroup Practices Pharmacies

– Health Care PlansHMOs Health Insurers MedicarePBMs Group Health Plans Medicaid

– Health Care ClearinghousesEntities that transmit data into a HIPAA “standard” format from anon-standard format or vice versa

• “Business Associates” of HIPAA Covered EntitiesEntities that use protected health information (PHI) for or on

behalf of covered entities


6

What is permitted?

• HIPAA Covered Entities must obtain one-time patient consents and then may use “protected health information” (PHI) only for TPO:– Treatment of patients

– Payment for treatment

– Health Care Operations

NOTE: The August 14, 2002 revisions replace the requirement of consent for TPO with an obligation to seek written verifications that data subjects have been provided with a covered entity’s notice of privacy practices.


7

HIPAA Impact On Biomedical Research

• Pharmaceutical industry research sponsors generally are not HIPAA Covered Entities or Business Associates of such entities.

• Virtually all entities through which pharmaceutical companies conduct human-subject biomedical research are HIPAA Covered Entities.

• There may be multiple Covered Entities involved in a clinical study (e.g., Study Site and Clinical Laboratory).

• Research is not included in TPO.


8

HIPAA Research Requirements

Uses or disclosures of PHI for research require:• Signed, HIPAA compliant “authorizations” from each study

participant, in addition to HIPAA consents and Common Rule informed consents;

• IRB or “Privacy Board” waivers of some or all of the authorization requirements; or

• “De-identification” of patient data via one of two methods:– Removing each of 18 prescribed data elements; or– Statistical Analysis and opinion

NOTE: The August 14, 2002 revisions allow the HIPAA authorization to be combined with a Common Rule informed consent.

NOTE: The August 14, 2002 revisions create a limited identifiable data set that will be very useful for epidemiologic and outcomes research. Given restrictions on use, this data set would likely not be useful in clinical research.


9

HIPAA Research Requirements - Cont.

Covered Entities Must Also:• Provide detailed notices of their privacy policies and

practices to all study participants;• Provide physical, technical and administrative security;• Allow data subjects to access and correct PHI about them.• Disclose the minimum PHI necessary to achieve the

authorized purposes; and• Document and provide, on request, an accounting of all

disclosures of PHI for research purposes.

NOTE: The August 14, 2002 revisions eliminate the minimum necessary and accounting requirements for research conducted under HIPAA Authorizations.


10

Authorizations

HIPAA Authorizations Must:• Be written in plain language and signed by each study participant;• Specify the data that will be collected and each use to which it will be

put;• Specify the persons, or types of persons, who will have access to the

data;• Specify a date or event after which the covered entity will no longer

collect, use or disclose the data, or state that the authorization will not expire;

• State that the individual may refuse to sign or revoke the authorization at any time and that data collected before revocation will continue to be used;

• State that once the data are provided to the study sponsor, HIPAA will no longer protect them; and

• Disclose any payments from the sponsor to the investigator for use or disclosure of the data.


11

De-identification (Two Methods)

HIPAA Safe Harbor 45 CFR 164.514(b)(2)(i)• Names• Geographic subdivisions smaller than a state• Zip codes• Dates (birth, admission, discharge, death)• Age, if over 89• Telephone numbers• Fax numbers• E-mail addresses• Social security numbers• Medical record numbers• Health plan beneficiary numbers• Account numbers• Certificate and license numbers• Vehicle identification and serial numbers• License plate numbers• Device identifiers and serial numbers• URLs• Internet Protocol address numbers• Biometric identifiers (finger and voice prints)• Full face photos and comparable images• Any other unique identifiers

Statistical 45 CRF 164.514(b)(1)

• A person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable;

• Determines that the risk of re-identification of the data, alone or in combination with other reasonably available data, is very small; and

• Documents the methods and results.


12

“Limited Use” Data Set

Allowed• Admission Dates

• Discharge Dates

• Service Dates

• Death Date

• Age (in hours, months or days)

• Age (for those over 90)

• Five Digit Zip Codes

Not Allowed• Names• Street Addresses• Telephone and Fax Numbers• e-Mail Addresses• Social Security Numbers• Certificate or License Numbers• Vehicle ID and Serial Numbers• URLs and IP Addresses• Full Face Photos and

Comparable Images• Medical Record Numbers


13

Waivers and Alterations (HIPAA vs. CR)

HIPAA 45 CFR 164.512(i)(2)(ii)

A. Use or disclosure involves no more than minimal risk to the privacy of individuals, as indicated by F-H below;

B. Alteration or waiver will not adversely affect privacy rights and welfare of individuals;

C. Research could not practicably be conducted without the alteration or waiver;

D. Research could not practicably be conducted without access to and use of PHI;

E. Privacy risks to individuals are reasonable in relation to the anticipated benefits if any, to the individuals, and the importance of the knowledge that may be reasonably expected to result from the research;

F. Adequate plan to protect identifiers from improper use and disclosure;

G. Adequate plan to destroy identifiers at the earliest opportunity, unless there is a health or research justification or legal requirement to retain them; and

H. Adequate written assurances that PHI will not be reused or disclosed for other purposes.

Common Rule 45 CFR

46.116(d)

A. Research involves no more than minimal risk to subjects;

B. Waiver or alteration will not adversely affect the rights and welfare of subjects;

C. Research could not practicably be carried out without the waiver or alteration; and

D. Whenever appropriate, subjects will be provided with additional pertinent information after participation


14

ExceptionsCovered entities may use and disclose PHI withoutauthorizations, waivers, or de-identification where:• the disclosure is to a person who is subject to FDA jurisdiction

with respect to a product for which that person has responsibility, and is required for the purpose of activities related to the quality, safety or effectiveness of the product, including to:– collect or report adverse events;– track products;– enable product recalls, repairs or replacements; or– conduct post-marketing surveillance.

• the information is used in preparation for research (e.g., protocol development), provided that it does not leave the covered entity; or

• the information relates to deceased individuals.


15

HIPAA Transition Provisions

Transition (Grandfather) Provisions for Research ThatIncludes Treatment:• For patients who sign informed consents before April 14, 2003:

– data collected before April 14, 2003 may be used and disclosed for research after April 14, 2003 without the need for authorizations; and

– data may be collected, used and disclosed for research after April 14, 2003 without the need for authorizations, provided that

– data are collected, used and disclosed in consistently with the Common Rule informed consents.

• Research authorizations required for patients who sign Common Rule informed consents on or after April 14, 2003.

Note: The August 14, 2002 revisions adopt this transition provision for all research regardless of whether treatment is involved, and for research conducted pursuant to an IRB waiver of informed consent obtained prior to April 14, 2003.


16

HIPAA Transition Provisions

Transition Provisions for Research That Does NotInclude Treatment:• If informed consents are obtained before April 14, 2003,

researchers may rely on such consents to use and disclose data created or received before April 14, 2003, but not after.

• Research authorizations are required for patients who sign informed consents on or after April 14, 2003.

• Research authorizations are required where patients did not sign informed consents to participate in research.

NOTE: The August 14, 2002 revisions eliminate this provision and adopt the transition provisions set forth on the preceding slide for all research.


17

HIPAA Liability

Violations of HIPAA can result in:• Civil sanctions on covered entities

• Criminal sanctions

• Interruption of data collection, use and disclosure by covered entities


18

Impact On Clinical Research

As a practical matter, each of the following will be required to conduct CLINICAL studies under HIPAA:– Common Rule Informed Consent to participate in the study– HIPAA Consent for treatment, payment and health care operations– HIPAA Authorization to allow use of existing medical records for

research– HIPAA Authorization to allow the study site to collect, use and

disclose PHI to the sponsor for research purposes– HIPAA Notice of Privacy Practices detailing covered entities’ HIPAA

compliant policies and procedures.

NOTE: The August 14, 2002 revisions replace the HIPAA Consent requirement with an obligation to seek verifications that data subjects have been provided with a covered entity’s notice of privacy practices.

NOTE: The August 14, 2002 revisions allow an authorization to be combined with a Common Rule consent.


19

Impact On Public Health Research

As a practical matter, the following will be required to conduct non-clinical EPIDEMIOLOGIC and OUTCOMES research under HIPAA:– HIPAA Authorization to allow use of existing medical

records for research; or– IRB Waiver of some or all of the Authorization

requirements.OR

– Use of partially identifiable data under an agreement with the providing Covered Entity that binds the researcher to use and disclose the data only for research and public health purposes, and to not re-identify or contact any data subject.


20

Assessing HIPAA Readiness

Before engaging a U.S. study site, research sponsorsshould verify that the site:• Posts its notice of privacy practices and seeks

written acknowledgement from patients that they have received copies;

• Maintains HIPAA policies and procedures;• Has a privacy officer and a contact person to

receive complaints;• Has implemented technical, physical and

administrative security for patient information; and• Has provided and documented HIPAA training for

its employees.


21

Monitoring HIPAA Compliance

Once a decision is made to engage a U.S. study site,sponsor monitors should verify that:• Consent forms used at the site meet the HIPAA authorization

requirements;• Final CRFs, workbooks, and other documents provided to the

sponsor contain only the identifiable patient information that is to be disclosed to the sponsor in accordance with the consents/authorizations and protocol;

• Hard copy patient information is maintained securely, electronic systems are password protected, and access to records is given on a need-to-know basis;

• The site has documented and responded to any study participant requests for access; and

• Any confidentiality breaches are addressed and resolved.


22

Practical Implications• August 14, 2002 revisions are practical and appropriate and

will reduce HIPAA’s negative impact on research;• More conservative IRB scrutiny of research protocols,

consent forms, authorizations and waiver requests;• Attempts by some research institutions to contractually

impose HIPAA Business Associate requirements on pharmaceutical company research sponsors;

• Increased paperwork, expense, time and difficulty in enrolling patients and administering studies;

• Need for pre-contract consideration by research sponsors of research partner HIPAA compliance; and

• Greater reluctance amongst U.S. physicians to provide AE and pregnancy registry information to pharmaceutical companies.


23

HIPAA Impact Management Strategy

Update Merck Consent Templates to address HIPAA. Educate internally regarding HIPAA’s impact on Merck

research. Establish criteria for evaluating the HIPAA readiness of

U.S. research sites. Engage pharmaceutical industry research sponsors, leading

research institutions, IRBs and trade associations in discussions regarding the practical impact of HIPAA on research and build consensus regarding key issues and appropriate solutions.

Monitor and respond to emergence of “tougher” U.S. state laws.


24

Questions?

Download - Oliver Johnson, Esq. Chief Privacy Officer Merck & Co., Inc

Top Related