HIPAA (Health Insurance Portability and Accountability Act).

Introduction

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that
required the creation of national standards to protect sensitive patient health information from
being disclosed without the patient’s consent or knowledge. The act intends to protect private
and sensitive patient data from hospitals, insurance companies, and healthcare providers. IPAA
compliance is regulated by the Department of Health and Human Services (HHS) and the
provisions of the Act are enforced by the Office for Civil Rights (OCR).

HIPAA Privacy Rule

The HIPAA Privacy rule protects all the individual information regarding their health
conditions(known as protected health information or PHI) that is held or transmitted by a
covered entity or a BA. This information can be held in any form. Including digital, paper or oral.

The Privacy Rule also contains the rights of an individual to understand and control how their
health information is used. The major goal of the rule is to make sure that individual health
information is properly protected while allowing the necessary information to be transferred in
need for providing better healthcare service to the individual, and to protect the wellbeing of the
patient. The Privacy Rule allows the important use of information about patient health while
protecting the privacy of the patient or an individual who seeks healthcare treatment.

The PHI includes but is not limited to the following:

● A patient name, address, date of birth, Social security number, biometric identifications
or other personal identification information.
● An individual’s past, present, or future physical or mental health condition
● Any type of treatment provided to the individual

PHI does not include the following:

● The employment records, including education about the person's education, as well as
other records.

Types of Organizations:
1. Covered Entities- Any type of company or organization which provides treatment,
operations, and payment in healthcare and as a result creates, collects or transmits PHI
electronically is considered a converted entity. Example: Healthcare providers, Health
insurance providers and healthcare clearinghouses.
2. Business associates- Any company that has access to PHI and provides support in the
form of treatment or operations is considered as a business associate. Example IT
providers, electronic health records platforms, etc.
HIPAA Security Rule
While the Privacy Rule safeguards the health information, this rule focuses on the technical and
physical safeguards that healthcare entities must implement to ensure the confidentiality,
integrity, and availability of electronic protected health information (ePHI). It mandates
administrative, physical, and technical measures to protect against unauthorized access, data
breaches, and other security risks.
To ensure the secure transmission, maintenance, and receipt of PHI, the rule mandates the
implementation of safeguards, both physical and electronic. Healthcare organizations should
ask three crucial risk analysis questions when addressing the risks and vulnerabilities related to
PHI and ePHI.
1. Can the sources of ePHI and PHI within the organization -- including all PHI created,
received, maintained or transmitted -- be identified?
2. What are the external sources of PHI?
3. What are the human, natural and environmental threats to information systems that
contain ePHI and PHI?

HIPAA Privacy Rule Penalties.

Under the breach of medical information of a patient could result in a fine from OCR(Office of
Civil Rights) to the Organisation or an individual. Depending on the severity the offenses are
split into four categories:
1. Unknowingly violating HIPAA is $100 per violation, with an annual maximum of $25,000
for repeat violations.
2. Reasonable cause for violating HIPAA is $1,000 per violation, with an annual maximum
of $100,000 for repeat violations.
3. Willful neglect of HIPAA, but the violation is corrected within a given time period, is
$10,000 per violation, with an annual maximum of $250,000 for repeat violations.
4. Willful neglect of HIPAA, and the violation remains uncorrected, is $50,000 per violation,
with an annual maximum of $1.5 million for repeat violations.

A punishment of up to $50,000 and up to a year in jail are possible for covered businesses and
people who knowingly collect or disclose PHI in violation of the HIPAA Privacy Rule. Penalties
can be escalated to a $100,000 fine and up to 10 years in jail if the HIPAA Privacy Rule is
broken under false pretenses.

Through HIPAA compliance training programs, organizations can lessen their risk of regulatory
action. OCR provides advice through educational initiatives on adhering to security and privacy
regulations. Programs are also provided by a variety of consultancies and training
organizations. Healthcare providers may also decide to design their own training courses, which
frequently cover their current HIPAA privacy and security guidelines, the HITECH Act, and
mobile device management (MDM) procedures.
What sector is mainly affect by HIPAA
The healthcare and medical sector is where HIPAA (Health Insurance Portability and
Accountability Act) originated. It is a key piece of law in the United States that handles the
privacy of patients, data security, and the portability of health insurance coverage, among other
things, in the context of healthcare information. The major objective of HIPAA is to guarantee
patient privacy and security while protecting sensitive health information within the healthcare
sector.

Some of the industry leading figures in US Healthcare industry and their info:

Dr. Atul Gawande:

Dr. Atul Gawande is a prominent surgeon, author, and public health researcher. He has written
extensively on healthcare, including books like "Being Mortal" and "The Checklist Manifesto."
https://www.atulgawande.com/

Dr. Sanjay Gupta:

Dr. Sanjay Gupta is a neurosurgeon, medical correspondent for CNN, and author. He covers
medical news and contributes to public health discussions through his media work.
https://www.cnn.com/profiles/sanjay-gupta-profile
https://www.facebook.com/SanjayGuptaMD

Dr. David Katz:

Dr. David Katz is a preventive medicine specialist and advocate for lifestyle-based approaches
to health. He has authored numerous books and is a sought-after speaker on topics related to
nutrition and public health.
https://www.davidkatzmd.com/
https://www.linkedin.com/in/david-l-katz-md-mph-4798667

Dr. Ezekiel Emanuel:

Dr. Ezekiel Emanuel is a bioethicist, oncologist, and healthcare policy expert. He has been
involved in shaping healthcare policy and is known for his contributions to discussions on
healthcare reform.
https://hcmg.wharton.upenn.edu/profile/zemanuel/
https://www.linkedin.com/in/zeke-emanuel-6ab78a1b0?
challengeId=AQFRQwws3lX1wQAAAYoj1zfAKFhAYaG5wZ2d2UVzEUDS9GBtSxHSDaKnHlLK
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1b7b3455cc2c&challengeSource=AgGZA-
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uSKaxWl2brTuE&challegeType=AgE9elPFzNTy6QAAAYoj19SA6R20rHrxGubLZBg230azMDO
Nv2Y1j3Y&memberId=AgHa7cqr2LZpkQAAAYoj19SDX1Uc0B44S9ZmYpPm32ZducI&recogniz
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HIPAA in Healthcare Industry:
Healthcare organizations that handle protected health information (PHI) or electronic protected
health information (ePHI) are the main target audience for the Health Insurance Portability and
Accountability Act (HIPAA). These organizations are in charge of protecting the confidentiality
and security of patients' sensitive health information. Here are some of the principal clients to
reach for HIPAA compliance:
1. Healthcare Providers: This includes hospitals, clinics, doctors' offices, nursing homes,
and other healthcare facilities that collect, store, and transmit patients' health
information.
2. Health Plans: Health insurance companies, HMOs (Health Maintenance Organizations),
and other health plans that process and manage insurance claims and medical records.
3. Healthcare Clearinghouses: Organizations that process nonstandard health
information into standard formats for electronic submission to health plans.
4. Business Associates: These are third-party entities that provide services to covered
entities (healthcare providers, health plans, or healthcare clearinghouses) involving the
use or disclosure of PHI. Business associates might include medical billing companies,
IT service providers, cloud storage providers, and more.
5. Healthcare Contractors and Subcontractors: Organizations that provide services to or
on behalf of business associates that involve PHI.
6. Researchers: Those involved in medical research that use patient data must adhere to
HIPAA guidelines when accessing and using PHI for research purposes.
7. Pharmacies: Pharmacies and pharmacists who process prescriptions and maintain
patient medication records.
8. Laboratories: Medical testing laboratories that process and store patient samples and
data.
9. Telehealth Providers: As telehealth services become more common, providers offering
remote healthcare services must also comply with HIPAA rules and regulations.
10. Medical Device Manufacturers: Companies that produce medical devices and
technologies that collect or transmit patient data must ensure their products comply with
HIPAA requirements.

HIPAA's major objective is to safeguard the security and privacy of patient health information
and to make sure that it is handled and shared throughout the healthcare ecosystem in an
appropriate manner. The confidentiality and integrity of this sensitive data must be maintained
by covered businesses and their business partners by putting measures and procedures in
place.
ADVANTAGES OF HIPAA
1. Patient Privacy Protection:
Sensitive patient health information, often known as protected health information (PHI),
is subject to tight rules set forth by HIPAA. This helps prevent unauthorized disclosure
and guarantees that people have control over who can access their health information.
2. Data Security Enhancements:
HIPAA demands that covered entities put security safeguards in place to protect
electronic protected health information (ePHI). The risk of data breaches is decreased by
these measures, which include encryption, access controls, and frequent security
evaluations.
3. Patient Access to Health Records:
HIPAA permits patients to access and obtain copies of their medical records. This
promotes transparency, patient engagement, and allows individuals to be better
informed about their health conditions and treatment options

HIPAA has evolved with the changing healthcare landscape over the years.
Telehealth and COVID-19: COVID19 led to temporary waivers and guidance for telehealth
services, which balanced patient privacy with increased access to care during a public health
emergency.
Strengthened Enforcement: In recent years, HIPAA enforcement has increased significantly,
with substantial penalties for violations. Resulting in substantial penalties for noncompliance.
This shows the importance of protecting patient data and maintaining regulatory contancy.

Patient Access: HIPAA guidelines have also evolved with the 21st century Cures Act
provisions, which have made it easier for patients to access their EHRs. This allows patients to
engage and control their health information while still adhering to HIPAA's security measures.

Emerging Technologies: As healthcare continues to integrate AI and machine learning

technologies, HIPAA guidelines continue to evolve to ensure that these technologies protect
patient privacy. HIPAA has clear protocols for de-identification of data and encryption to ensure
confidentiality.

Latest amendments on HIPAA

1. HIPAA Omnibus Rule (2013): This rule implemented changes to HIPAA regulations in
response to the HITECH Act, enhancing privacy and security protections. It addressed
issues like business associate liability, breach notification requirements, and the use of
patient data for marketing purposes.

2. 21st Century Cures Act (2016): This act introduced provisions to make it easier for
patients to access their electronic health records (EHRs) and share them with caregivers
and other healthcare providers. It also aimed to improve interoperability and data
exchange among different healthcare systems.
 3. HIPAA Enforcement Rule Updates: The HHS periodically updates the HIPAA
enforcement rules to clarify penalty tiers, settlement amounts, and processes for
investigating and addressing violations.

4. COVID-19-Related Changes: During the COVID-19 pandemic, temporary waivers and

relaxations were introduced to allow for expanded telehealth services and remote patient
care, while maintaining HIPAA compliance to the extent possible.

5. Advancements in Health IT: As technologies like AI, machine learning, and cloud
computing become more prevalent in healthcare, there may have been updates or
guidance related to their use under HIPAA regulations to ensure patient data security
and privacy.

HIPAA is a legal framework rather than a commercial product, so it doesn't have direct
competitors in the traditional sense. But it shares similarity with its European model of
healthcare law standardized to all over europe which is GDPR(General Data Protection
Regulation)
HIPAA (US):
HIPAA seeks to protect the privacy and security of protected health information (PHI) in the US
healthcare industry. Scope: This applies to covered entities (health care providers, health plans,
health services) and their business associates. Key Features: Focuses on health information;
has special requirements for protected electronic health information (ePHI); promote privacy,
security and patient rights; emphasizes fulfillment and fulfillment. Market Size: The US
healthcare industry is huge, with healthcare spending projected to exceed $3.8 trillion in 2021.

GDPR (European Union):

GDPR is a comprehensive data protection rule that applies to all industries in the member
states of the European Union (EU). Although not only focused on health care, it has
implications for health information. Scope: This applies to all entities that process personal data
of EU residents. Key Features: Addresses the protection of personal data, including health
information; emphasizes consent, transparency, data rights, data breach reporting and
accountability; heavy fines are imposed for violations. Market size: The impact of GDPR covers
a number of industries in the EU 27, including healthcare. The gross domestic product (GDP) of
the entire EU economy is more than 15 trillion dollars
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