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HIPAA compliance requires special focus and effort as failure to comply carries significant risk of damage and penalties. A practice with multiple separate systems for patient scheduling, electronic medical records, and billing, requires multiple separate HIPAA management efforts. This article presents an integrated approach to HIPAA compliance and outlines key HIPAA terminology

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

, principles, and requirements to help the practice owner to ensure HIPAA compliance by medical billing service and software vendors.

The last decade of the previous century witnessed accelerating proliferation of digital technology in health care, which, along with reduced costs and greater service quality, introduced new and greater risks for accidental disclosure of personal h

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

alth information.

The Health insurance Portability and Accountability Act (HIPAA) was passed in 1996 by Congress to establish national standards for privacy and security of personal health data. The Privacy Rule, written by the US Department of Health and Human Services took effect on April 14, 2003.

Failure to comply with HIPAA risks accreditation and reputation damage, lawsui

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ts by federal government, financial penalties, ranging from $100 to $250,000, and imprisonment, ranging from one year to ten years.

Protected Health Information (PHI)

The key term of HIPAA is Protected Health Information (PHI), which includes anything that can be used to identify an individual and any information shared with other health care providers or clearinghouses

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

in any media (digital, verbal, recorded voice, faxed, printed, or written). Information that can be used to identify an individual includes:

Name
Dates (except year)
Zip code of more than 3 digits, telephone and fax numbers, email
Social security numbers
Medical record numbers
Health plan numbers

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

License numbers

Photographs

Information shared with other healthcare providers or clearinghouses

Nursing and physician notes
Billing and other treatment records

Principles of HIPAA

HIPAA intends to allow smooth flow of PHI for healthcare operations subject to patient's consent but prohibit any flow

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

f unauthorized PHI for any other purposes. Healthcare operations include treatment, payment, care quality assessment, competence review training, accreditation, insurance rating, auditing, and legal procedures.

HIPAA promotes fair information practices and requires those with access to PHI to safeguard it. Fair information practices means that a subject must be allowed

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

Access to PHI,

Correction for errors and completeness, and

Knowledge of others who use PHI

Safeguarding of PHI means that the persons that hold PHI must

Be accountable for own use and disclosure
Have a legal recourse to combat violations

HIPAA Implementation Process

HIPAA implementation begins upo

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

making assumptions about PHI disclosure threat model. The implementation includes both pre-emptive and retroactive controls and involves process, technology, and personnel aspects.

A threat model helps understanding the purpose of HIPAA implementation process. It includes assumptions about

Threat nature (Accidental disclosure by insiders? Access for profit? ),
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
>
Source of threat (outsider or insider?),
Means of potential threat (break in, physical intrusion, computer hack, virus?),
Specific kind of data at risk (patient identification, financials, medical?), and
Scale (how many patient records threatened?).

HIPAA process must include clearly stated policy, educational materials and eve

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ts, clear enforcement means, a schedule for testing of HIPAA compliance, and means for continued transparency about HIPAA compliance. Stated policy typically includes a statement of least privilege data access to complete the job, definition of PHI and incident monitoring and reporting procedures. Educational materials may include case studies, control questions, and a schedule o

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

f review seminars for personnel.

Technology Requirements for HIPAA Compliance

Technology implementation of HIPAA proceeds in stages from logical data definition to physical data center to network.

To assure physical data center security, the manager must
1. Lock data center
2. Manage access list
3. Track data center access wit

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

closed circuit TV cameras to monitor both internal and external building activities

Protect access to data center with 24 x 7 onsite security

Protect backup data

Test recovery procedure

For network security, the data center must have special facilities for

Secure networking - firewall protection, encrypt

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ed data transfer only

Network access monitoring and report auditing

For data security, the manager must have

Individual authentication - individual logins and passwords
Role Based Access Control (see below)
Audit trails - all access to all data fields tracked and recorded
Data discipline - Limite

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ability to download data

Role Based Access Control (RBAC)

RBAC improves convenience and flexibility of systems management. Greater convenience helps reducing the errors of commission and omission in granting access privileges to users. Greater flexibility helps implement the policy of least privilege, where the users are granted only as much

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

privileges as required for completing their job.

RBAC promotes economies of scale, because the frequency of changes of role definition for a single user is higher than the frequency of changes of role definitions across entire organization. Thus, to make a massive change of privileges for a large number of users with same set of privileges, the administrator only makes changes t

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

the role definition.

Hierarchical RBAC further promotes economies of scale and reduces the likelihood of errors. It allows redefining roles by inheriting privileges assigned to roles in the higher hierarchical level.

RBAC is based on establishing a set of user profiles or roles according to responsibilities. Each role has a predefined set of privileges. The user acquires pr

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ivileges by receiving membership in the role or assignment of a profile by the administrator.

Every time when the definition of the role changes along with the set of privileges that is required to complete the job associated with the role, the administrator needs only to redefine the privileges of the role. The privileges of all of the users that have this role get redefined au

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

omatically.

Similarly, if the role of a single user is changed, the only operation that needs to be performed is the reassignment of the user profile, which will redefine user's access privileges automatically according to the new profile.

Summary

HIPAA compliance requires special practice management attention. A practice with multiple separate systems for scheduling,

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

electronic medical records, and billing, requires multiple separate HIPAA management efforts. An integrated system reduces the complexity of HIPAA implementation. By outsourcing technology to a HIPAA-compliant vendor of vericle-like technology solution on an ASP or SaaS basis, HIPAA management overhead can be eliminated (see companion papers on ASP and SaaS for medical billing)

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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