Exploration of Regulations and Implications for Apple Health Records

This report provides an in-depth analysis of Apple's Health Records project, examining its functionalities, stakeholders, and goals. It delves into safety practices, such as the use of FHIR standards and data encryption, while also addressing ethical considerations like data misappropriation and uberveillance. The report highlights regulatory considerations, including the project's classification as a medical device and its adherence to standards like HIPAA and HITECH Act. Furthermore, it discusses the standards of practice followed by the project to ensure patient privacy and data security. The conclusion summarizes the key findings, emphasizing the importance of ethical considerations and regulatory compliance for the success of the project. The report is a comprehensive assessment of the Apple Health Records system, its impact, and its adherence to established guidelines.

Running head: EXPLORATION OF REGULATIONS AND IMPLICATIONS FOR
PRACTICE
EXPLORATION OF REGULATIONS AND IMPLICATIONS FOR PRACTICE
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Table of Contents
Introduction....................................................................................................................2
Discussion......................................................................................................................2
Overview of the informatics project..........................................................................2
Analysis of the project...............................................................................................3
Conclusion......................................................................................................................6
References......................................................................................................................7

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Introduction
Additionally, along with equipping the nurses as well as doctors with the improved
tools that have been designed for improving the patient health as well as the delivery of the
care, the health informatics is presently introducing the innovative possibilities for the
patients for becoming increasingly engaged in their respective care. The Apple Company has
been able to develop the personalised Health records systems that provides the facility of
reshaping the patient engagement. This report intends to analyse the Health records system of
the Apple Company and determine the effectiveness of the new informatics project.
Discussion
Overview of the informatics project
Apple has been able to develop the applications of healthcare for the iPhones as well
as the tablets that allows the both the providers as well as the patients with the instant access
to the complete medical records of the patient (Guo et al., 2018). Working in the conjunction
with several conventional patient portals that are used by the several health organisations, the
Apple system effectively and securely transfers the medical data of the patient to Health
Records app for allowing the providers as well as the patient to view the data in familiar, ease
of using interface. The high resolution as well as the extensively powerful capabilities of
graphics even provides the Doctors with the ability of viewing the imaging studies of the
patient on the iPad. Along with enabling the care providers in working extensively efficiently
on the behalf of the patient, the most exciting prospect of program is that it allows the
patients in improved management of their respective care as well as connect remotely with
the providers among the visits (Dinev et al., 2016). The main stakeholders of the project of
Apple company are the Project sponsor, the customers, program management, project
management, business analysts, project team, functional managers, designers and the local

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communities. The intended goal of the initiative of the Apple company is the implementation
of improved methods of healthcare management for the customers (Yuan et al., 2019). The
actual goal of the initiative is the introduction of the improved healthcare management
system using the mobile application of the end users. This project of the Apple company has
helped significantly huge amount of people in managing the health data and ensure that they
have the proper knowledge of their respective conditions. The doctors could now easily
diagnose any serious condition of the patients before it becomes incurable (Premarathne et
al., 2017). The prospect where in the past, the medical records of the patients were managed
in the several locations, needs the patients to login into the website of each of the providers
and then piece the information manually, the health project of the Apple company has helped
the healthcare community in taking the consumer friendly approach by creating the health
records depending on the FHIR (Fast Healthcare Interoperability Resources), which is the
standard for the transfer of the electronic medical records.
Analysis of the project
Safety practices
The application of health management of Apple company makes it significantly easier
than earlier times for the users to properly visualise as well as securely store all the health
records. Presently the patients could integrate the health records from the several institutions
along with the patient generated data, developing the increasingly holistics view of the health
of the patient (Lin, Jha & Adler-Milstein, 2018). As the patients possess all the medical
information properly organisation within one view right on the iPhone, it could help them in
improved understanding of the complete health as well as offer the crucial elements of the
medical history when they visit any new doctor. There are several safety practices in the
health application of Apple. The connection among the electronic health record as well as the
health app of the users primarily uses the FHIR standard APIs as it has been defined by the

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researchers (Kohli & Tan, 2016). The supported data types are the allergies, immunisations,
conditions, medications, lab results, vitals as well as the procedures. The application
primarily provides the seamless connection. This connection mainly leverages the OAuth 2.0
that allows any users in authenticating once as well as create the enduring connection to the
APIs of the EHR. Health app would periodically connect to the EHR APIs for pulling the
new health records as well as notify any user when the new records are accessible (Sohn &
Yeo, 2019). When the data of the health record is transmitted from any healthcare institution
to health app, it has been effectively encrypted and do not traverse the network of Apple.
When the iPhone of users has been locked with the passcode, the Face ID or the Touch ID,
the health data within this health app has been encrypted on-device.
Ethical considerations
The main ethical consideration with the health project of Apple is related to the data
misappropriation. This particular concern mainly arises from the questioning of the
originality of apps as well as the clarity on the location where the accumulation of the data is
being done as well as manipulated (Giordanengo et al., 2018). The data misappropriation
could be described as unauthorised utilisation of the data of the users, deprived of proper
permission as well as the consent that has the potential of resulting into extensive harm. One
more ethical concern associated with this project is the uberveillance. Uberveillance mainly
includes the identity as well as the location tracking that is consistent as well as embedded
within the technology artefact that is ad automatic in real time. Another concerning issue with
the health informatics project of Apple company is the legal inadequacy in the health app.
There is significant lack of effective policies that helps in governing the emerging
technologies like the apps and even if the policies are implemented, there are inadequate
policing of the policies that ensures the efficient implementation (Neinstein et al., 2020). The
main ethical concern associated with the health app of informatics project is the privacy

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infringement. The aspect of privacy that has been discussed within this mostly denotes to
separation of the user data as well as the personal privacy. This particular privacy has the
direct link with the security of the user data (Dameff, Clay & Longhurst, 2019).
Regulatory considerations
From the regulatory viewpoint, the project of digital health technologies like the
health informatics of Apple might be defined as the project of development of medical
devices if they are intended for using within the diagnosis, the cure, treatment, mitigation, or
the prevention of the disease or if function or structure of human body from the non-chemical
action (Lau & Haut, 2017). It mainly includes the devices that takes the measurements for
providing the users with all the required information regarding the conditions. The medical
devices could be effectively include what takes the measurements for providing the users
with the required information regarding the conditions. The medical devices could be
effectively classified into the one of the three categories with the various levels of the
regulatory control that is based on individual risk or benefit profile of device (Bachiri et al.,
2018).
Standards of Practice
The standards of practice mainly includes the method of how discipline or the clinical
specialty. It includes the policy statements of the clinics, the standards of practice, the
standard operating processes, the protocols of clinical practice as well as the clinical
procedures. The policy statements mainly clarifies the scope as well authority associated with
the particular activity by the definition of what activity can be done by any individual, with
the level of supervision that would be implemented and the time of implementing the activity
(Dinh-Le et al., 2019). The health application project of Apple follows the HIPAA, The
HITECH Act, MACRA and the medical necessity for ensuring that all the standards of

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practice of healthcare are followed. The HIPAA mainly ensures that the privacy of the patient
healthcare information is maintained effectively. The project of Apple considered this
standard and followed the boundaries on utilisation as well as the release of the health
records. The safeguards are outlined for protecting the information of the patient and it also
established the civil as well as the criminal penalties for the violations. The HITECH Act has
been followed for ensuring that the promotion of adoption as well as the meaningful use of
the information technology in healthcare. The project ensures that it mandates the audits of
the healthcare providers for determining whether compliance with the HIPAA privacy rules
are considered associated with the security as well as the privacy rules.
Conclusion
Therefore, it could be concluded from the above discussion that the informatics
project of personalised Health records systems is following all the rules as well as the
regulations for ensuring that the project is successful and maintains the ethical issues. The
main ethical consideration with the health project of Apple is related to the data
misappropriation. This particular concern mainly arises from the questioning of the
originality of apps as well as the clarity on the location where the accumulation of the data is
being done as well as manipulated.

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References
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Dameff, C., Clay, B., & Longhurst, C. A. (2019). Personal health records: more promising in
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