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A massive amount of clinical data is generated daily. Advancement in ICT technologies has enabled the healthcare providers to store them digitally and referred to as Electronic Health Record (EHR). These records are shared with various stakeholders, like doctors, nursing staff, and healthcare providers. These health records are also accessible to government agencies, pharmacies, laboratories, insurance agencies with consent or some time without consent. These personal health details recorded in EHR systems are sensitive information and can cause financial, social, and health issues if leaked. Blockchain technology has emerged as an immutable and reliable ledger that can maintain anonymity and immutability in EHR systems. There are many regional and international regulations to guide the safety and privacy of sensitive health records. Prominent among these regulations are the Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR). This paper analyses Blockchain-based EHR system compliance with HIPAA and GDPR and further areas of improvement.
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Compliance with HIPAA and GDPR in blockchain-based electronic health
record
Mohammed Shuaib
a,b
, Shadab Alam
b,
, Mohammad Shabbir Alam
b
, Mohammad Shahnawaz Nasir
b
a
Razak Faculty of Technology and Informatics, University Teknologi Malaysia, Malaysia
b
Department of Computer Science, College of C.S. & IT, Jazan University, Jazan, Saudi Arabia
article info
Article history:
Available online xxxx
Keywords:
EHR
HIPAA GDPR
Privacy
Blockchain
abstract
A massive amount of clinical data is generated daily. Advancement in ICT technologies has enabled the
healthcare providers to store them digitally and referred to as Electronic Health Record (EHR). These
records are shared with various stakeholders, like doctors, nursing staff, and healthcare providers.
These health records are also accessible to government agencies, pharmacies, laboratories, insurance
agencies with consent or some time without consent. These personal health details recorded in EHR sys-
tems are sensitive information and can cause financial, social, and health issues if leaked. Blockchain
technology has emerged as an immutable and reliable ledger that can maintain anonymity and
immutability in EHR systems. There are many regional and international regulations to guide the safety
and privacy of sensitive health records. Prominent among these regulations are the Health Insurance
Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR). This paper
analyses Blockchain-based EHR system compliance with HIPAA and GDPR and further areas of
improvement.
Ó2021 Elsevier Ltd. All rights reserved.
Selection and peer-review under responsibility of the scientific committee of the International Virtual
Conference on Sustainable Materials (IVCSM-2k20).
1. Introduction
Clinical information is produced by current patient clinical test-
ing. These services are typically performed in pathology labs, hos-
pitals, or clinics through different tests and radiology reports.
These instruments generate large amounts of clinical data world-
wide, and their volumes are growing exponentially. Clinical data
is projected to rise sharply [1]. Clinical Data produced in regular
clinical tests are stored in a paper based format in most developing
countries. Medical professionals follow this strategy, as it is easy
and does not need advanced ICT knowledge. However, keeping
paper-based patient information is not helpful for patients and
cannot offer reliable and timely health care. Other problems
related to paper-based medical records are:
1. Records may be modified simply and are loss prone that is a
serious problem.
2. Healthcare professionals may prescribe incorrect medicines
(due to changes in paper-based medical records) or may not
recommend correct medications during patient visits without
a proper history of records.
3. Not always possible for a patient to bring cumbersome manual
paper health records for discussion with the doctor during
appointments or explain medical history if a doctor or hospital
changes.
4. Updating and analyzing paper records is a lengthy process for
new doctors or medical personnel in case of change of hospitals
or doctor.
Health organizations use procedures to digitize medical records
to solve the problems described above [2]. Currently, patient clin-
ical data are kept as EHR. EHR is computerized health records of
patients containing complete patient information and treatment
records in a design (described in Fig. 1) which is easily shareable
or retrieved by various health care providers via other linked sites
as required [3].
The use of EHR has many advantages over conventional paper-
based mechanism. For instance:
https://doi.org/10.1016/j.matpr.2021.03.059
2214-7853/Ó2021 Elsevier Ltd. All rights reserved.
Selection and peer-review under responsibility of the scientific committee of the International Virtual Conference on Sustainable Materials (IVCSM-2k20).
Corresponding author.
E-mail address: s4shadab@gmail.com (S. Alam).
Materials Today: Proceedings xxx (xxxx) xxx
Contents lists available at ScienceDirect
Materials Today: Proceedings
journal homepage: www.elsevier.com/locate/matpr
Please cite this article as: M. Shuaib, S. Alam, M. Shabbir Alam et al., Compliance with HIPAA and GDPR in blockchain-based electronic health record, Mate-
rials Today: Proceedings, https://doi.org/10.1016/j.matpr.2021.03.059
1. EHR can store structured, encrypted and detailed patient health
history [4].
2. EHR provides a base for medical decision support system (DSS)
to regularly monitor the patient’s health status and enhance
healthcare quality [5]. DSS facilitates decision-making by
automating data analysis [6].
3. EHR acts as centralized storage for tracking and billing patients,
maintaining quality and facilitating patient-sensitive decision
making.
4. Records stored in EHRs can be used by different collaborating
parties at different locations readily. Hence, supplying data to
interested physicians across multiple locations to provide effi-
cient and quality health facilities.
5. EHR decreases the risk of medical data processing errors by
storing full medical records, thereby reducing healthcare costs
[7].
With the advantages of the use of EHR in healthcare, various
specific issues are also identified. The most pertinent issue is
record security and privacy of the patient. If EHR data is somehow
accessed in an unauthorized way, it can be dangerously misused
like drug or treatment changes unsafe for patients and can result
in serious problems or cause patient death [8]. Therefore, it is nec-
essary to protect patient information from the wrong people’s
unwanted hands in the central database. Patient information
may also be stolen when transmitted across the network to several
other networks or stored in distributed cloud servers [9 10 11].
EHR can also be used for various secondary purposes like clini-
cal studies, health insurance, clinical audit, and government
decision-making support. Additionally, it can be used for preven-
tion campaigns, national standards audits, national forecasts,
future service planning, resource allocations, etc. [12]. Patients
may not disclose their health information for benefit; it only shares
their personal health data for treatment and not other secondary
uses. The use of patient personal data for various secondary activ-
ities without their consent would significantly disturb patient
privacy.
To protect the privacy of the patient; the various privacy stan-
dards followed in different regions are GDPR in Europe [10] and
HIPAA in the United States [13]. This paper reviews the HIPAA
and GDPR privacy standards and identified its challenges to pro-
vide data privacy for the growing EHR information. Further, the
paper is organized as follows: Section II provides an outline of
EHR and various EHR standards. Section III summarises the
requirements for HIPAA and GDPR compliance. Section IV
describes the proposed solutions for HIPAA and GDPR compliance
in EHR. Finally, in Section V, conclude the paper.
2. Electronic health record (HER) standards
The EHR data must be shared among various interconnected
sites, such as dispensaries, hospitals, pharmacies, diagnostic labs
etc., for effective use [14] shown in Fig. 1. Sharing data at numer-
ous locations ensure flexible and effective patient treatment by
identifying the essential needs like care, support, safety, timeliness,
and monitoring needs. It supports professionals (physicists, nurses,
etc.) in making the right decisions based on symptoms [15 16 17].
Data accessibility is further improved if EHR data are connected to
different clinical databases and decision support systems (DSS).
CDSS are automatic medical data analysis platform that recom-
mends more care interventions and generates warnings through
Fig. 1. A conceptual overview of EHR Systems.
M. Shuaib, S. Alam, M. Shabbir Alam et al. Materials Today: Proceedings xxx (xxxx) xxx
2
data analysis predicting future conditions/trends. Physicians can
make wise decisions easily and virtually [18].
EHR data sharing across multiple locations is complicated.
Without a health information exchange and privacy standard.
Healthcare providers encountered the same problem when sharing
EHR data and various DSSs, as there was no standard for privacy
and sharing health information. It s a key factor behind the low
adoption rate for EHR in healthcare organizations, although EHR’s
introduction in healthcare is very beneficial [19].
2.1. Health level seven (HL7) standard
In March 1987, the HL7 organization was founded in the U.S. to
providing accurate, common Hospital Information System (HIS)
standards. This organization-defined HL7 hospital Document
Architecture (HL7 HDA) as the communication standard for easy
integration, exchange, sharing and retrieval of information through
various health information systems. HL7 enables various health-
care institutions to share patient data through encrypted data ex-
change. It offers information syntax for various health information
systems to conveniently exchange information using EHR [20].
HL7 CDA describes the structure and syntax of EHR data ele-
ments, such as discharge files, registration summaries, progress
reports and procedures, and shares with different stakeholders.
XML encrypts HL7 CDA clinical data and exchanges HL7 messages
and other transfer solutions.
2.2. Fast healthcare interoperability resources (FHIR)
HL7 has published periodic versions to enhance interoperability
and knowledge sharing. Version 2 of HL7 was published in 1988 to
improve and streamline the information-sharing mechanisms/pro-
cedures that a large hospital can use [21]. However, this version
exposed numerous shortcomings, such as a complicated creation
process and a lack of adequate recognition capability of recogniz-
ing communication and interface techniques [22]. Version 2 was
planned in 1995 to fix the shortcomings. While HL7 version 3 fixed
several of the drawbacks of earlier versions but failed to solve the
incompatibility problem due to various subversions [23]. Another
new requirement for interoperability, i.e. to develop the HL7 spec-
ifications further. In 2011, HL7 introduced Fast Healthcare Interop-
erability Tools (FHIR) [24]. FHIR standards are essential for
adaptation, scalability and robust design. Such standards would
enable workflows in small devices such as mobile phones [13].
3. Prevalent data protection regulations and their challenges
Authorities have enforced data protection regulations in certain
parts of the world to secure personal health records from various
security threats and attacks. A most prevalent data protection reg-
ulations are the GDPR [25], and HIPAA [13].
In this paper, we critically reviewed these regulations, including
how to preserve patient privacy and enforce data security. The
GDPR came into force in all E.U. countries on May 26, 2018, remov-
ing its previous Data Protection regulations in 1995 [26]. GDPR is a
regulation that became E.U. law and needed to be followed by all E.
U. members. This integration of E.U. law includes all personal infor-
mation, including health data, stored, exchanged and used. The
handling of health data by E.U. citizens is likely to cost and benefit
healthcare practitioners and health analysts.
3.1. General provisions of the GDPR
The GDPR defines ‘‘personal data” as a ‘‘data subject” that
include all information to identify an individual. Theoretically,
GDPR applies to all ‘‘controllers” and ‘‘processors” dealing with
the personal data irrespective of their location [2728]. Judicial
duties of controllers and processors are similar, but the controller
has primary access to the sensitive data subjects [26].
While processing depends on consent, the user should be cap-
able of withholding consent at any moment, and the process
should be as simple as giving consent. Controllers are responsible
for proving consent. Parental consent is generally required for
underage subjects [29].
GDPR gives individuals many significant privileges, including:
Right to know the collection of data.
The Right to access to information.
Right portability of data;
Right to object to storage;
Right to resolve incorrect data;
Highly controversial (particularly in the context of the Right to
free speech) rights to forget’ when data is no longer preserved.
E.U. Data Protection Authorities may fines offenders up to 4% of
gross revenue, and individuals can have private legal rights
against controllers and processors [3031].
3.2. Applying GDPR in healthcare
GDPR has many criteria for health data and scientific study.
Overall, data collection, use, and transmission for health and scien-
tific purposes are becoming more regulated, strengthening the
DPD’s rules patchwork. Specific rules are complex and typically
more burdensome than previous laws. Specific rules apply to
health and personal genetic data, deemed ‘‘sensitive.” Many speci-
fic guidelines and conditions need to be followed before processing
any such information [32]. The Condition included that ‘‘explicit”
consent has been granted to the data subject if:
Securing a data subject for patients unable to give consent like
an unconscious patient’s medical emergency;
When it is essential to offer health care as if one doctor needs
data from other doctor or healthcare provider;
To address health needs, such as protection from cross- border
health threats or preserving health safety.
4. Health insurance portability and Accountability Act (HIPAA)
4.1. General provisions of HIPAA
HIPAA regulates U.S. protected health information (PHI) usage
and disclosure. HIPAA describes PHI as providing information
about a per- son’s mental or physical health. HIPAA refers only to
a sub-set of organizations—health care plans, health care payment
systems; (i.e., business associates). HIPAA includes protected orga-
nizations and associations to provide security and privacy to PHI.
Generally, protected organizations and business associates cannot
disclose or use PHI without prior patient approval unless an excep-
tion exists [33]. HIPAA provides for reasonably broad exemptions
to this general rule [3435].
4.2. Applying HIPAA in healthcare
HIPAA also regulates whether to use PHI for research purposes.
Researchers can acquire, create, use or disclose PHI during
research. However, typically covered organizations have underly-
ing data researchers [36]. The covered organizations must either
have the patient’s permission to reveal such information for
research work or have recorded approval from the Institutional
Review Board (IRB) or the Privacy Board to reveal such information
M. Shuaib, S. Alam, M. Shabbir Alam et al. Materials Today: Proceedings xxx (xxxx) xxx
3
without patient permission [37] disclose such information to
researchers.
Since IRB endorsement of relinquishment for patient authoriza-
tion can be a complex process, most researchers opt for patient
authorization if they agree to the study. Protected organizations
can also provide information [38].
5. Requirements for HIPAA and the GDPR compliance solution
To collect and use health data alone in the USA for research,
medical or any other related purposes remains controlled by HIPAA
(and in some cases applicable state law) and is not affected by
GDPR. However, the GDPR must be complied with in every ‘‘pro-
cessing” like collection, application, or retention of personal infor-
mation identifiable for an individual in the E.U. Similarly, entities
which obtain health data from EU-based individuals will have to
meet strict GDPR requirements for whatever reason. Organizations
that transfer U.S. health-related data to the European Union must
comply with both rules.
Despite conceptual parallels and some similarities — such as
excluding the anonymous data from reportage — HIPAA and the
Common Law standards are not equivalent, on the one hand, and
GDPR, on the other. Consequently, none is assumed to cooperate
to ensure complete conformity with the healthcare system. There
are some main functional differences:
1. The Institutional Review Board (IRB) does not guarantee that
GDPR consent provisions have complied. IRB approvals are car-
ried out separately. Nevertheless, GDPR demands will seldom
be waived if the consent-based processing of health data within
an institution in the E.U. starts with the need for the GDPR and
guarantees that the U.S. informed consent records meet the
standard.
2. The rights of EU GDPR data subjects go well beyond the stan-
dard of an informed U.S. Consent agreement — GDPR access,
corrections and erasure rights, for example. Organizations gath-
ering or otherwise processing E.U. data should first become
familiar with these rights. Again, the approval and compliance
of the US IRB may be insufficient.
3. The GDPR one-stop shopping law simplified in almost every
case. It also imposes conditions that cannot be ignored, includ-
ing the naming of a delegate to the chosen E.U. country’s data
protection authority.
4. The transfer of data from E.U. members to the U.S. based mem-
bers is most is often the most complex part. The guidelines are
precise and normally uncompromising, but it is possible, mainly
by consensus, so this is a different problem that needs to be
tackled in every international health data project design
process.
6. Proposed HIPAA and GDPR compliance solution for
healthcare
HIPAA and GDPR also require effective technical measures,
namely pseudonymization and encryption, to secure health data.
It’s not easy to implement these correctly, and it will require exten-
sive development resources. Fig. 2 shows the HIPAA and GDPR
compliance requirements for healthcare.
1. The technological requirements remain organizational respon-
sibility. Further measures, such as adequate encryption and
audit records, are required. There is no level of security you
need to add to AWS, Azure, etc. These requirements, however,
are difficult to implement and ultimately require a professional
development team.
2. Organization’s cloud provider typically manages firewalls, load
balancing systems, etc. Also, these should be mounted properly.
3. Administrative requirements can be allocated to attorneys. But
they cannot still complete documents such as DPIAs or BAAs.
6.1. Encryption
Data encryption protects data using cryptography. There are
various encryption methods. Many cloud providers also provide
encryption, as well. However, there’s not enough for GDPR or
HIPAA. Individuals can display or process health data using
application-level encryption. End-to-end encryption could be use-
ful for securing physician-patient conversations.
Data can be encrypted in many ways, but three approaches are
suitable for health data. None of the cloud providers offers these
methods by default.
1. Encryption at the database level: the whole database has been
encrypted as a group. Its solution is not very safe and can be
opened immediately.
2. Application-level encryption: Each patient record is encrypted
individually. It’s also a good choice over database-level encryp-
tion, as every key unlocks only one record.
3. End-to-end encryption: E2E encryption. Records are encrypted
at the end of the device using private keys. It’s a safe approach
if you don’t even need access to the backend info.
6.2. Pseudonymization
Pseudonymisation is the process of replacing all your personal
data (or personal identity Information) with random pseudonyms.
The mapping between pseudonyms and data must be stored
securely and separately. The key advantage of pseudonymization
will be that you can store your sensitive data (e.g. health data) in
an easily accessible location, so you can easily create new applica-
tions using this data. It is important to note, that GDPR considers
such data as personal data as indirect identifiers can re-identify a
user.
Pseudonymisation can be used when stored securely but still
available (e.g., searching). It’s known as a secure GDPR and HIPAA
technique.
The explanation of how pseudonymous work in health care is
discussed below.
1. Initial patient health record: full details in the original form.
2. Distinct health records from personal data: personal informa-
tion about each patient is extracted from their health records
and stored elsewhere.
3. Randomly generate pseudonyms: a unique identification code
is created to connect individuals.
4. Keep a nickname for each health record: personal information
and health records are stored with the same identification code.
6.3. Anonymisation
Anonymisation requires the complete deletion of personal data
and then handling the remaining data to delete indirect identifiers.
The goal is to ensure that the remaining data cannot be re-
identified by a person. The standard anonymization strategy is a
generalization, flipping disruption, aggregation. Right anonymiza-
tion is extremely difficult, as Netflix discovered early in 2008.
The problem is, the specification differs depending on how special
the data is. For example, if you have a group of 20 patients, but only
one is over 50, rounding the ages to the nearest whole number is
ineffective. Significant research has been carried out on initiatives
to ensure anonymous data, e.g. k-anonymity.
M. Shuaib, S. Alam, M. Shabbir Alam et al. Materials Today: Proceedings xxx (xxxx) xxx
4
There are no privacy laws to cover anonymized data, and ana-
lytical data may be used or shared with others. But anonymization
privileges are difficult. Anonymisation rights are difficult.
The explanation of how anonymization work in health care is
discussed below.
1. Numerous initial health records: the original full data in the
original format
2. Effectively damaged personal identifiers: simple personal data
is deleted and cannot be recovered later.
3. Health data are modified to avoid re-identification: this can be
achieved in several different ways, through masking, random
sampling, generalization and noise-adding.
4. Analysis-ready data: data can be studied or transmitted without
the risk of identifying patients.
7. Conclusion
EHR systems are storing essential and sensitive health informa-
tion that need secure and privacy, preserving solution. Blockchain-
based EHR systems are a possible solution to fulfil these needs. For
providing privacy and security needs the GDPR and HIPAA regula-
tions guide principle, but implementing them in EHR systems is
difficult. This paper has reviewed the compliance of Blockchain-
based EHR systems on compliance with GDPR and HIPAA require-
ments. Blockchain-based EHR systems support encrypted, pseudo-
nymized anonymous record storage essential for GDPR and HIPAA
compliance. Hence it has been reviewed, and it is ascertained that
these systems can comply with the GDPR and HIPAA guidelines if
they follow the described physical, technical and administrative
requirements.
Declaration of Competing Interest
The authors declare that they have no known competing finan-
cial interests or personal relationships that could have appeared
to influence the work reported in this paper.
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