The
health & life sciences industry is highly complex as well as regulated
which is selected to conduct this research. In this industry, successful
organizations like payors, health care providers, and the industry care
providers are well experienced for the regulatory requirements and compliance
navigation. The industry of health & life sciences strictly meets with
HIPAA compliances. The US health & life Sciences organizations are already governed
by HIPAA which has a very strong base of the privacy of the data as well as the
experience of legal compliance at the time of coming to the implementation of
GDPR. Furthermore, such organizations will highly give the advantages of a
strong compliance mindset (Foth, 2016).
There
are some different kinds of overarching laws identified for the US health &
life sciences industry. The laws are related
to the privacy of the medical data in the hospitals or in the other medical
centers. The anarchy law for this the industry is that the US Privacy laws
including protected health information which is completely defined by HIPAA.
Furthermore, the processing of personal data is broadly regulated by GDPR
through an entity that falls with the GDPR scope.
Standards or principles helpful
for development and implementation
The
standards or the principles which are helpful for the development and the
implementations of GDPR are determined and discussed in this document. GDPR has
set out seven different types of principles which are: fairness, transparency,
and lawfulness, minimization of the data, limitation purpose, limitation in the
storage, accountability, accuracy as well as integrity and confidentiality, or
the security of the healthcare confidential information. Some changes are also
done into the principles. There was any principle for individual rights, so it
has been dealt with. For the development and the implementation of GDPR in the
health & life sciences industry, HIPAA as a framework is used to provide
the protection of the medical data into the organizations and its databases. GDPR
is using a different kind of practices to make the system effective and the
more valuable in which the data of health & life sciences organizations
will be more secure. The data which is collected from the users, the privacy
policy tells about the actual reason and purpose of taking information from the
users. Secondly, the staff of the organizations is well maintained and
providing their services in an effective way to protect the users’ information.
Most importantly, the best practice is that the staff always tries to keep
update the data inventory by maintaining the security structure (GDPR Implementation and HIPAA Compliance: An
Analysis of the GDPR and HIPAA for U.S. Health & Life Sciences
Organizations, 2018).
Critical
data infrastructure assets
It
is identified and discussed the critical data infrastructure assets in this
section that is describing the physical and cyber systems or assets. the
physical and virtual assets, systems, as well as the networks, are included in
the critical data infrastructure assets of the US health & lifer sciences
organizations that impact on the national economic security, the security of
the organizations and the public health. The system which is used in healthcare
organizations around the world is completely based on the digital system. Some organizations
still are using the manual record system and use the paper files to note down
and save the data of the hospitals. But now the healthcare departments are also
focusing on the digital systems. The website panel is used to collect the
information from the users who work or are operated under the HIPAA. The mobile
applications have also introduced and the patients can use those applications to
provide information. In the organizations, the data centers and separate IT
offices are also made that always provide support to the infrastructure of the
company.
Human Resources for Technical,
Management and Legal Operations
The
human resource is very important and effective in organizations. So that’s why
the US health & life sciences organizations also need human resources to resolve
the technical and the issues in the healthcare sector. It is determined that the
human resource information system which is proposed by HIPAA is used in the US
health & life sciences organizations that typically provide more
information and provide more data-driven solutions. This data-driven solution allows
the staff to craft the reports form the depth for audit purposes. It is also
useful to manage the employees working in the organization and help to take
legal actions in case of an emergency.
Requisite law enforcement
entities
HIPAA
is applying its rules with law enforcement investigations. There are three
major rules or the law entities which are defined by HIPAA. The covered law
enforcement entities are health plans, healthcare services, provider's rules as
well as the healthcare clearinghouse. Furthermore, the law is also enforcing
the healthcare communities and organizations to keep the data of the users.
References of
Industry-specific compliance
Foth, M. (2016). Factors influencing the intention to
comply with data protection regulations in hospitals: based on gender
differences in behaviour and deterrence. . European Journal of Information
Systems, 25(2), 91-109.
GDPR Implementation and HIPAA Compliance:
An Analysis of the GDPR and HIPAA for U.S. Health & Life Sciences
Organizations. (2018). GDPR Compliance, 1-14.