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American College of Medical Practice Executives Professional Paper EXPLORATORY This paper is being submitted in partial fulfillment of the requirements of Fellowship in the American College of Medical Practice Executives. Anna McGuigan Morse FACMPE August 25th, 2018 Getting Your Practice into HIPAA Compliance

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Page 1: Getting Your Practice into HIPAA Compliance · no standardized compliance plan for a medical practice due to the vast array of medical practices providing patient care, the available

American College of Medical Practice Executives Professional Paper

EXPLORATORY

This paper is being submitted in partial fulfillment of the requirements of Fellowship in the American College of Medical Practice Executives.

Anna McGuigan Morse FACMPE

August 25th, 2018

Getting Your Practice into HIPAA Compliance

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INTRODUCTION

“Integrity is doing the right thing, even if nobody is watching”

- Jim Stovall

Understanding the Health Insurance Portability and Accountability

Act (HIPAA) and how HIPAA laws are incorporated into a medical practice

is essential. “Ignorantia legis neminem excusat is a legal principal holding

that a person who is unaware of a law may not escape liability for violating

the law merely because one was unaware of its content” (Campbell Black).

HIPAA was created to develop rules that protect the privacy and

security of health care information. HIPAA comprises of five major

categories: The Privacy Rule, the Security Rule, the Transaction Rule, the

Identifiers Rule, the Enforcement Rule, and the Health Information

Technology for Economic and Clinical Health (HITECH) Act. The laws of

HIPAA are essential for the efficient management of a medical practice.

PURPOSE

This paper’s purpose is to inform managers about the importance of

HIPAA in a medical practice. It is also to encourage practices to have a

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compliance plan in place to ensure that the practices abide by HIPAA laws.

This exploratory paper focuses primarily on the Privacy and Security Rule

along with the importance of implementing the policies and procedures into

a medical practice.

Research methodologies utilized will include an extensive literature

search of reviewed journal articles, discussions with medical management,

peer-reviewed articles from the Medical Group Management Association

(MGMA) website and Connection Magazine and other online articles.

BACKGROUND

National standards to protect individuals’ medical records and other

health information are found in the Privacy Rule. (45 CFR Parts 160 and

Part 164). This rule establishes patients’ rights. The most noted form

needed in a practice is the Notice of Privacy Practices. This form explains

how a practice may use and disclose protected health information (PHI).

Also practices will likely prepare pre-printed forms for patient record access,

restrictions, disclosures, use, and privacy complaints.

The electronic protected health information (ePHI) standards and

procedures are found in the Security Rule. The Rule covers administrative,

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technical and physical safeguards. It includes hardware, software,

transmission security, disaster backup, recovery plan, and incident response.

HIPAA was initially created to develop rules protecting the privacy

and security of health care information. Millions of dollars in fines are

collected annually for failure to comply with HIPAA laws and, in some

cases, criminal charges resulting in jail time can be brought against medical

practioners.1 With the knowledge of HIPAA regulations, violations can be

prevented by implementing policies and procedures to comply with HIPAA

regulations.

As technology develops at a rapid pace, the concern for security

increased rapidly. Providers routinely access clinical data from outside their

practice and many practices have incorporated e-prescribing into their daily

operations. In addition, providers have exchanged paper charts for

electronic medical records (EMR).

As more practices enter the technological age of health care, HIPAA

guidelines have expanded to reflect these changes. Any practice that

transmits any health information electronically is considered to be a covered

entity and therefore must comply with the rules and regulations of HIPAA—

no matter the size of the practice.

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Consequently, having a formal written compliance program is now

Federal law. (Patient Protection and Affordable Care Act 2010). A medical

practice cannot overlook or be lax about HIPAA, nor can the medial practice

be inconsistent with their enforcement.

HISTORY

Before HIPAA, originally known as the Kennedy-Kassenbaum bill,

rules and regulations lacked uniformity, varied by state and brought

confusion because there were no standards of authority for enforcement of

violations.2 Now HIPAA is a succession of federal laws that all practices

must adopt. Practices must focus on implementing good procedures within a

practice to protect the availability and integrity of electronic protected health

information and patient privacy.

Prior to HIPAA many providers were unsure about how the rules and

regulations applied to them or how compliance plans would function in their

practices. Passwords for access to patient data were minimally or not

protected at all since many medical employees had a habit of forgetting

passwords and simply posted them on their computers. Patient information

was left on desks and even in an examining room with inconsistent

protection of the patient’s personal and medical information. Patient

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information was released to a consultant specialist or an organization

without having the patient sign a medical release form granting permission

to share their medical information. Training was limited with few reminders

not to discuss patient information in public places.

As health care progressed with modern technology, e.g. electronic

medical records, the need for laws about privacy and security became

apparent. Congress recognized that with the increased use of electronic

technology in the medical community there came the increased risk of

abuse. This resulted in the need to establish security and privacy parameters.

Although HIPAA was passed in 1996, it continues to be reviewed and

updated not only by Congress but also by the Secretary of the United States

Department of Health and Human Services (HHS). HIPAA encompassed

the changes in society and the evolution of new technologies that are

replacing paper medical records with electronic medical records systems.

PRESENT DAY HIPAA

The Privacy Rule

HIPAA has developed rules such as the Privacy Rule that gives

patients the right to oversee their health information, along with sets of

limitations on who can look at and receive their health information. The

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Privacy Rule applies to all forms of individual protected health information,

whether electronic, written or oral. It protects “individually identifiable

health information.” (45 CFR 160.103) These national standards are meant

to protect individuals’ medical record and other personal health identifiable

information. This set of rules apply to health plans, health care

organizations, health care providers and those working with covered entities

such as healthcare clearing houses and business associates.

Privacy rules should not interfere with patient care and the operations

of the practice. Consequently, patient information can be disclosed without

authorizations for treatment, payment, and operations aka TPO. Information

that is disclosed should be kept at “minimum necessary” to accomplish the

task and treatment.

When used for educational purposes with healthcare students,

disclosure should be given consideration so that the data remains

de-identified. There are instances where the disclosure of PHI does not

require patient authorizations. These instances include: physicians sharing

information with specialty consultants, child abuse, violent injuries, and in

legal trials when ordered by the court.3

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The standards are set by the federal law. However, there are

circumstances where state privacy laws hinder a practice’s ability to follow

both federal and state laws. In these circumstances, the Privacy Rule is

“preempted by the federal requirements, which means that the federal

requirements will apply” (HHS Office of the Secretary, Office for Civil

Rights, and OCR. “Summary”).

The Security Rule

The Security Rule requires security for health information which the

practice creates, receives, maintains or transmits in electronic form (HHS

Office of the Secretary, Office for Civil Rights, and OCR. “The Security

Rule.”). The practice must protect against threats to the security or integrity

of health information and guard the access to information from those who

are not permitted or required to access such information.

Practices may find the Security Rule difficult to handle solely in-

house, unless they have strong in-house technical support and legal advisors.

Simply stated: The Security Rule has three main groupings: Administrative,

Physical, and Technical. Examples might include: for administrative,

assigning employee access rights; the physical group could cover

workstations; and technical, automatic computer logoffs.

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All practices need a detailed breakdown of their operations to develop

a risk assessment, which would be a detailed analysis of the practice.

Perform a walk-through of the practice and for potential risks and breaches.

A disaster contingency plan is needed. What would the practice do in the

case of a hurricane and subsequent power loss? What is the plan for backing

up and the storage of data? Have a plan for re-using recycling hardware

equipment. Include encryption and decryption for electronic transmissions.4

DEVELOPING A COMPLIANCE PLAN

Medical practices are required to develop and implement formal

compliance policies that comply with their state and federal laws. There is

no standardized compliance plan for a medical practice due to the vast array

of medical practices providing patient care, the available practice resource

and the various types of medical care. No practice is exempt from being in

compliance with HIPAA regulations nor can they blame their non-

compliance on lack of training or understanding. The formal compliance

plan protects patient care services ensure billing for medical services are

based on documented services performed. It requires the constant auditing of

the practice’s operations, adherence to government regulations, and training

of employees, providers, and volunteers.

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The compliance plan should be followed by the entire workforce

within the practice with no exclusions or special exemptions. If an

individual is on the practice’s payroll, a volunteer, trainee, member of the

Board of Directors, a student in the practice, business associate, or

contractor, then such individual must to adhere to the practice’s compliance

program. Unless the employee has direct job-related reasons to review the

medical record, the employee has no reason to open a medical record.

By having a formal compliance plan the practice is communicating to

their staff and the medical community that they are meeting their legal

obligations and are committed to conduct their practice in an ethical manner

with proper employee conduct. For practices large and small, this is a huge

challenge as health care compliance is layered with both state and federal

laws that change on a regular basis.

Many practices have a point person who is responsible for overseeing

HIPAA compliance in the practice. Some practices may breakdown the

roles with one overseeing patient privacy (Privacy Rule) and the other for

security (The Security Rule).

BUSINESS ASSOCIATES AGREEMENTS (BAA)

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Another section of the compliance plan is to include Business

Associate Agreements (BAA). The majority of medical practices use some

vendors or contractors to assist in daily operations of the practice. Under

HIPAA, persons outside the practice who use or have access to the practice’s

patients’ PHI or (ePHI) in performing services i.e. transcription, patient

billing, cloud storage companies, attorneys, and computer management

companies are classified as Business Associates.

A discussion and on-going dialogue should be held with the business

company examining parameters for disclosing PHI both in paper and

electronic format. If business associates use subcontractors, they too must

agree to the same standards as business associates.

Termination of the business associate’s contract includes termination

of provisions and mandatory surrender and/or destruction of PHI. “OIG has

the authority to exclude individuals and entities from federally funded health

care programs pursuant to section 1128 of the Social Security Act (Act) [sic]

(and from Medicare and State health care programs under section 1156 of

the Act) and maintain a list of current excluded individuals and entities

called The List of Excluded Individuals/Entities (LEIE). Anyone who hires

an individual or entity on the LEIE may be subject to civil monetary

penalties” (oig.hhs.gov/exclusions/index.asp)

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The list of business associates should be documented in the

compliance plan; LEIE should be reviewed monthly by the Compliance

Officer. A copy of the signed agreement, which has been reviewed and

indicates what the Business Associate will be do, should be included in the

compliance plan. Best practice would be to have legal counsel review the

agreement before it is signed.

If the practice does not have a business associate agreement template,

the practice can obtain a generic agreement from legal counsel. Templates

are also available on many medical management and medical association

websites. In addition, there are HIPAA compliance companies on the

internet that do offer BAA. No matter where a business associate agreement

is maintained it is still required by HIPAA Privacy and Security Rules to

disclose PHI to the BAA. “OCR specifically reminded covered entities and

business associates in October 2017 that using a cloud service provider to

maintain PHI without entering into a BAA violates HIPAA rules and that

cloud service arrangements need to be accounted for in risk analysis and risk

management.” (Driscoll, Hindmond, Simmons, 2018)

BREACHES AND VIOLATIONS

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Failure to follow HIPAA laws or being lax about HIPAA compliance

could result in violations and penalties in the thousands to millions of dollars

in fines, including loss of license, loss of confidence from your patients, and

a tarnished reputation in the medical community resulting in decreased

referrals or even jail time.

The practice no longer needs to prove if the data has been

compromised just that the data was sent to the wrong person, a malware

attack occurred, or there was loss/theft of unencrypted devices. The breaches

indicate a HIPAA violation occurred, unless the practice can prove

otherwise.

Examples of Reportable Breaches and Documentation

If a patient’s information is left in an employee’s car, and the car is

stolen and the employee fails to report this loss of information to their

superiors, this would constitute a breach.

On a larger scale another HIPAA breach resulted in severe fines when

more than 4 million medical records on backup tapes were jeopardized. The

tapes were kept on four different laptops. These laptops were reportedly

stolen from the employee’s car. As a result of the records leaving the

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employee’s possession, a class action lawsuit was filed for the amount of

$4.9 billion, $1,000 for each person affected (Vogel),

An isolated incident is a violation of protected health information that

does not follow HIPAA’s policies and procedures. For example if a patient’s

medical health information was faxed and the recipient of the fax was not

the intended recipient; the recipient should then follow the procedure that is

enclosed on the disclaimer located on the fax cover sheet.

The practice would document the incident in their established risk

assessment. The documentation should include the process, the response

procedure, including a timeframe of when the violation occurred (start/end),

how and when it was discovered, the number of individuals affected, the

type of breach (loss, theft, hacking, unauthorized access) and a review on

why the incorrect fax number was used i.e. preprogrammed incorrectly into

the fax machine, physically misdialed, number is simply incorrect or the

ownership of the number has been changed. The final log in the risk

assessment would note that the correct fax number was adjusted and the staff

was informed of the error and retrained on the proper procedures to follow in

transmitting patient information.

“According to the National Health Care Anti-Fraud Association

(NHCAA), indicates healthcare [sic] fraud financial losses are in the tens of

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billions of dollars each year. In 2013, the US HHS and the Department of

Justice received more than $4.3 billion in healthcare [sic] fraud and abuse”

(Zabel, 2016).

REPORTING BREACHES AND VIOLATIONS

A covered entity must notify affected individuals, and the Secretary if

a breach of unsecured protected health information had occur, and, in certain

circumstances, to the media. The media would be advised if the breach

affected 500 or more residents of a State or an area plus post a notice in the

well-known media outlets serving that State or area. The notifications are

submitted to the Secretary using the specified Web portal (45 C.F.R. §

164.408).

The number of affected individuals in a breach is noteworthy as the

notification timeline will vary based on the number. “Notification of

affected individuals greater than 500 to the HHS and in some cases the

media for a breach of unsecured PHI; no later than 60 days following the

discovery of a breach; less than 500 affected individuals submit to HHS

annually for a HIPAA breach” (Centers for Medicare and Medicaid

Services).

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The affected individuals (greater than 500) must be informed by first-

class mail or by e-mail if the individual has agreed to receive such notices

electronically. (HHS Office of the Secretary, Office for Civil Rights, and

OCR. “Breach”).

Notification letters to affected individuals should include a brief

description of the occurrence, date of the breach, description of the type of

unsecured PHI that was involved such as demographics, social security

number, and the type of breach for example clinical or billing information.

Also, include the process that the practice will use to avoid future incidents.

The notification must include Compliance Officer contact information for

any questions about the breach that the recipient may wish to ask. The letter

would also recommend notifying credit card companies, and credit card

bureaus.

If there is insufficient or dated contact information for less than 10

affected individuals, then a written notice or telephone notification to the

next kin can be generated; greater than 10 affected individuals would include

a notice posted on the home page of the practice’s website, broadcast media

and a notice in print where the affected individuals live for a 90-day period

(HHS Office of the Secretary, Office for Civil Rights, and OCR. “Breach”).

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A toll-free phone number would be included for a 90 day period for

any call-in questions about the breach and also for individuals inquiring if

they were part of the breach.

As previously mentioned, the number of individuals involved in the

breach determines the timeline of reporting to the Secretary. If more than

500 individuals are affected, reporting is required 60 days after awareness.

If fewer than 500, individuals are affected, reporting can be submitted

annually via the Web portal.

Prompt notification is extremely important. Delay of a HIPAA

Breach notification is a violation of HIPAA. “Office for Civil Right (OCR)

pursued a case against Presence Health for unnecessarily delaying the

issuance of a breach notification letters. Presence Health become aware of

the breach on October 22, 2013, yet OCR was notified only on January 31,

2014. Presence Health had to pay a settlement of $475,000” (OCR).

If the breach involves Center for Medicare and Medicaid Services

(CMS) beneficiary’s information the Medicare Administrative Contractor

(MAC) might also be notified.5 The practice would check with their legal

counsel to see who would be needed to be contacted. A CMS breach could

involve someone other than Medicare beneficiaries using the beneficiary’s

Medicare card to obtain medical services e.g. medical identify theft.

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Another example could also include the Medicare beneficiary’s PHI being

included in back-up tapes that were brought home by a staff member, left in

the car and then the car was stolen.

Violations could occur in a medical practice of any size. The

difference is usually the number of affected individuals and the scope of the

violation. Depending on the size of the breach, notification might also

include the State Attorney General depending on State laws. The

Compliance Officer would meet with their legal counsel to review who

should be notified if needed.

Violations can come from in-house and outside sources. Outside

sources put a practice at risk, causing the practice to be the victim. For

example, malware, viruses, worms, spyware, Trojan horses, ransom-ware,

malicious software, and hacking can access a computer remotely without the

knowledge or consent of the user.6 In some cases; practices have been given

the option to pay a ransom.

COMPLIANCE OFFICER (S)

Hiring and Credentials

Depending on the size and resources of the practice e.g. small to

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mid-size, the Compliance Officer’s responsibilities can be handled in-house,

be contracted out to a health care compliance attorney or a health care

consultant. The officer must be familiar with HIPAA health care.

Preferably, the officer will hold certification such as a Certified Professional

Compliance Officer (CPCO).7

A practice should have at least one individual responsible for HIPAA

regulations. The role can be handled by one compliance officer who would

oversee all compliance and perform an initial risk assessment with annual

and periodic risk assessments. However, the responsibilities are frequently

divided into two roles: Compliance Privacy Officer and Compliance

Security Officer reporting to and under the direction of the senior partner or

Chief Executive Officer (CEO).

The Compliance Privacy Officer would oversee who has the right to

view the patient’s records and patient care. The officer would oversee

streamlining calls involving requests for patient information, ensure that the

practice receives proper authorization releases before sharing data; train staff

about patient information; and verify that the practice follows the Privacy

Rule in order to be compliant both in and outside the walls of the practice.

The Officer would also introduce and oversee various types of audits for

managing HIPAA operations within the practice. These audits would include

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evaluating the effectiveness of procedures, internal controls, accuracy, and

timely documentation and billing of patient services.

The Security Officer would focus on the safeguards of the ePHI to

ensure that information has controls in place so that there is no tempering,

viewing the record without authorization or stolen information. The officer

is responsible for the integrity of all software and hardware that contains

PHI. The main responsibilities include coordination, implementation and

testing of security measures for the practice’s computer network.

These responsibilities would include security measures and technical

solutions such as an unique user identification system to track employee

activities; data encryption, which is used when sending patient information;

firewalls, hardware devices and software applications; remote data wipe

programs; virus scanners; message authentication; digital signatures; privacy

screen protectors; usage of a Virtual Private Network (VPN), which creates

a temporary encrypted connection during time of use for remote access to

use data when working from a remote site; an emergency access procedure

to document instructions for access during an emergency situation (electrical

fire, flood, fire, explosion); a back-up procedure and schedule to protect the

practice’s data for all operations within the practice including a back-up in

the cloud; if applicable.

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The decision to have one compliance officer or to divide the position

into two is usually based on the size and need of the practice. Either way, as

long as HIPAA regulations are being overseen by an individual who has the

knowledge and understands the consequences on noncompliance.

In a small office, a “seasoned” in-house staff member could be the

compliance officer in addition to their primary role, often as the office

manager of the practice. A provider may also accept the role of compliance

officer. In a large organization, a high ranking individual from within the

organization could be appointed the sole responsibility of being the

compliance officer.

Another option is to conduct an outside search to hire an individual

whose skills would include HIPAA health care compliance knowledge, as

well as good people-skills, since training and educating staff at all levels will

be at the top of the job duties.

All compliance officers need a solid knowledge of computers as

healthcare is moving towards mobiles devices, electronic medical records,

cloud-based electronic health record and cloud-base storage. The officers

would also be required to promote a culture of compliance within the

practice and act as a role model for the staff to follow. The compliance

officer must obtain a commitment from senior management to have a

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successful compliant plan. Developing a Compliance Committee would also

be done by the compliance officer. The committee members would tailor

the plan based on the size of the practice, as no one size fits all.

A Committee

The Compliance Officer, as the Committee Chair, will promote a

culture of compliance by establishing a compliance committee. Based on

the size of the practice, committee members could vary and include

members such as senior leadership, operation team manager, a member of

the legal team, human resource manager, clinical manager, patient revenue

manager, and a member of the technical unit to brainstorm the elements

needed for an effective compliance program and to determine and evaluate

the risks of noncompliance.

The compliance committee would also approve policies for the

compliance plan developed by the compliance officer, as needed; revise

existing policies to stay current on related regulations. Periodic scheduled

discussions with committee members would include identifying training

tools necessary to educate and motivate the staff about compliance.

Staff Training

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Once security and privacy policies are in place, the staff should be

trained in proper HIPAA procedure during orientation. Some practices

allocate discussion questions and answer time during the employee’s annual

review.

To keep the staff up-to-date on HIPAA compliance, the compliance

officer can initiate a schedule for HIPAA compliance educational workshops

and staff meetings. The practice could include privacy and security topics in

newsletters and provide quizzes or simulations about compliance in the

practice.

All employees must know and understand what constitutes as PHI.

No one should start work without HIPAA training. “Include the key

elements of a HIPAA privacy Rule to include who is covered, what

information is protected, and how Protected Information (PHI) can be used

and disclosed” (HHS Office of the Secretary, Office for Civil Rights, and

OCR “Summary”).

PHI includes the patient’s demographic information, social security

number, full-face photos, a medical record number, and documentation of

any kind pertaining to the patient’s care i.e. clinical, billing, correspondence,

labs, radiology, prescriptions, and telephone intake messages.

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Training Manual

The compliance training manual should include the key elements of

HIPAA Privacy Rule “to include who is a covered, what information is

protected, and how Protected Health Information (PHI) can be used and

disclosed” (HHS Office of the Secretary, Office for Civil Rights, and OCR

“Summary”). The manual should contain what the staff needs to do to keep

PHI secure as it relates to their position in the practice.

The main focus of the manual is to provide the staff with the steps

needed for proper protection of individual’s health information, both on

paper and electronically. It should include information regarding internal

controls, to ensure that information is handled securely and protected by the

staff. When developing a HIPAA manual many specialty medical and

surgical societies have examples of HIPAA manuals for that specific field to

use as a reference. State medical societies will have resources to assist

practices in developing HIPAA manuals and what is needed to be in

compliance with HIPAA regulations. The practice’s mission statement

would be included in the introduction of the HIPAA manual to set out the

blueprint of the practice’s compliance plan.

For example, employees are advised to use a strong password that

includes letters, both uppercase and lowercase, as well as numbers and

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symbols. Passwords should never include identifying information of the

user. It should be noted that the officer will keep employee’s name and their

password, which would be changed periodically throughout the year, with

prior notice and a timeframe when the password would need to be change.

The manual should include the importance and use of locked shredding

containers to dispose of paper PHI.

A section of the manual will include on reporting an incident timely to

their manager or to the compliance officer. HIPAA incidents can be

reported in person, or through a nameless reporting process on a 24/7

anonymous hotline handled by a third-party vendor without punishment.

Many potential violations can be stopped from further escalating into a

HIPAA violation or fraud and abuse incident by timely reporting from the

staff.

The manual should also include what is done when there is improper

use of PHI and non-complaint behavior. For example, the range of action

could include retraining, counseling, disciplinary action e.g. verbal, written

up to and including immediate termination of employment. Civil or criminal

penalties could also occur.

It should be noted that senior management recognizes that

enforcement of HIPAA compliance is essential in a practice. No employee

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is exempted or excused for not complying with the practice’s compliance

manual. Those staff member who fail to be compliant will face

consequences for their actions as such behavior is not tolerated in the

practice.

HIPAA Resources

Besides in-house HIPAA training materials, there are additional

resources for HIPAA training that me be obtained from the Office for Civil

Rights (OCR), Medical Group Management Association (MGMA), State

Attorney General, Health Information Management Association (HIMA),

Centers for Medicare and Medicaid Services (CMS), Office of the Inspector

General (OIG), Office of National Coordinator for Health Information

Technology (ONC), and the American Medical Association.

SUMMARY

HIPAA compliance starts with awareness and understanding. With

the understanding of the various components of the law and their

importance, violations can be prevented by developing a compliance plan

sooner rather than later. HIPAA is frequently modified to reflect changes in

modern technology. The federal laws require all practices to be in HIPAA

compliance, which includes all ongoing adherences to HIPAA. If State laws

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conflict with the federal standards making it impossible to accomplish both,

the federal law preempts.

Most violations can be avoided by implementing policies and

procedures to comply with HIPAA regulations. Practices should have a

training program and a training manual, to reflect the policies and

procedures that cover privacy, access, security, accountability and reporting

breaches.

Practices must have a compliance officer – one who is knowledgeable

with the law. If a violation or breach does occur, investigation, tracking, and

timely reporting of the events is the responsibility of the HIPAA compliance

officer. Staff training and education on HIPAA by the compliance officer is

critical to have in today’s every-changing climate. At the staff training

sessions, it should be highlighted to never download anything from an email

address that the employee is not familiar with and report the incident to their

manager, IT or the compliance officer, in a timely manner.

As medical technology moves at a fast pace, the protection of medical

and personal information from unauthorized access continues to be a major

security risk. A practice must be diligent and include in their budget the

proper allocation of funds for its security, Protection against unauthorized

access such as ransomware attacks or computer viruses could not only cause

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a grave concern but could also be very costly and disrupt not only the

operations of the practice, but the care of the patients.

The medical practice can achieve the goal of being in compliance by

developing and keeping their compliance plan current. The providers should

work diligently to meet this goal in a reasonable manner and continue to

deliver the best patient care to their patients.

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Notes

1. Compliancy Group “HIPAA Violation & Breach Fines/List of HIPAA Violations” http://compliancy-group.com/hipaa-fines-directory-year/

2. Solove, Daniel J, “HIPAA Turns 10: Analyzing the Past, Present, and Future Impact” –Journal of AHIMA 84, No. 4 (April 2013): 22-28.

3. Richards, Edward, “When Can PHI Be Released without Authorization?” – The LSU Medical and Public Health Law Site, April 19, 2009

4. Federal Register, 45 CFR Parts 160, 162, and 164 Health Insurance Reform: Security Standards; Final Rule

5. “AB Medicare Administrative Contractor (MAC)-By State” www.cms.gov (Reviewed by IAC-2/2017)

6. Study.com “What is Malware?-Definition, Examples, & Types” http://study.com/academy/lesson/what-is=malware-definition-examples-types.html

7. AAPC. “Certified Professional Compliance Officer - CPCO™.” AAPC - Advancing the Business of Healthcare, AAPC Blog, www.aapc.com/certification/cpco.aspx.

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References

Campbell Black, Henry. “What Is IGNORANTIA LEGIS NON

EXCUSAT? Definition of IGNORANTIA LEGIS NON EXCUSAT

(Black's Law Dictionary).” The Law Dictionary, Black's Law

Dictionary, 28 Mar. 2013, thelawdictionary.org/ignorantia-legis-non-

excusat/.

Centers for Medicare and Medicaid Services. “HIPAA Basics for Providers:

Privacy, Security, and Breach Notification Rules.” CMS.gov,

Department of Health and Human Services, Aug. 2016,

www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-

MLN/MLNProducts/Downloads/HIPAAPrivacyandSecurity.pdf.

Driscoll A, Hindmand JD, R, Simmons, H (2018) “HIPAA wake-up call”.

MGMA Connection, 18(7), 29-31.

HHS Office of the Secretary, Office for Civil Rights, and OCR. “Breach

Notification Rule.” HHS.gov, HHS.gov, 26 July 2013,

www.hhs.gov/hipaa/for-professionals/breach-notification/index.html.

HHS Office of the Secretary, Office for Civil Rights, and OCR. “Privacy.”

Page 31: Getting Your Practice into HIPAA Compliance · no standardized compliance plan for a medical practice due to the vast array of medical practices providing patient care, the available

30  

HHS.gov, HHS.gov, 16 Apr. 2015, www.hhs.gov/hipaa/for-

professionals/privacy/index.html.

HHS Office of the Secretary,Office for Civil Rights, and OCR. “The

Security Rule.” HHS.gov, HHS.gov, 12 May 2017,

www.hhs.gov/hipaa/for-professionals/security/index.html.

HHS Office of the Secretary, Office for Civil Rights, and OCR. “Summary

of the HIPAA Privacy Rule.” HHS.gov, HHS.gov, 26 July 2013,

https://www.hhs.gov/hipaa/for-professionals/security/laws-

regulations/index.html;

OCR. “First HIPAA Enforcement Action for Lack of Timely Breach

Notification Settles for $475,000.” EveryCRSReport.com,

Congressional Research Service, 9 Jan. 2017, wayback.archive-

it.org/3926/20170127111957/https://www.hhs.gov/about/news/2017/0

1/09/first-hipaa-enforcement-action-lack-timely-breach-notification-

settles-475000.html.

Solove, Daniel. “BoK.” HIM Body of Knowledge, Journal of AHIMA, Apr.

2013, library.ahima.org/doc?oid.

Vogel, David. “Top 10 HIPAA Data Breaches of 2013.” Datapipe Blog,

Page 32: Getting Your Practice into HIPAA Compliance · no standardized compliance plan for a medical practice due to the vast array of medical practices providing patient care, the available

31  

Datapipe Blog, 7 Jan. 2014, www.datapipe.com/blog/2014/01/07/top-

hipaa-data-breaches-2013/.

Zabel, Laurie. “7 Elements for an Effective Health care Compliance

Program.” Physicians Practice, Physicians Practice, 6 July 2016,

www.physicianspractice.com/compliance/7-elements-effective-health

care-compliance-program