Cloud Computing is speeding up the way we create, share, and view data. With features such as multiple backups, high security, remote access, and auto-scalability, this platform of virtual computing is assisting health care providers and medical device manufacturers to improve their online led services, allowing greater flexibility in their business models. Indeed, it makes the system more robust and secure against data failures and an example of such a system is the Cloud-based EMR software system...

1. Enhancing EMR Systems Using Cloud
By: Govind Yatnalkar
Cloud Computing is speeding up the way we create, share, and view data. With features
such as multiple backups, high security, remote access, and auto-scalability, this platform of
virtual computing is assisting health care providers and medical device manufacturers to improve
their online led services, allowing greater flexibility in their business models. Indeed, it makes
the system more robust and secure against data failures and an example of such a system is the
Cloud-based EMR software system.1
EMR or Electronic Medical Records are the digitized patient records or charts which
document a patient’s medical and treatment history. These records are gathered from a single
source of medical practice and are not shared across other platforms. When EMRs are integrated
with Cloud and medical devices, they provide a myriad range ofcapabilities. As EMR applications
are hosted online on Cloud, they avoid the need to be accessed locally which not only enables
universal online access but also significantly increases security. Therefore, a common online
portal can be utilized by users to view data as well as record patient data on e-charts by health
professionals. Moreover, Cloud’s “Platform as A Service” model provides an entire suite of
advanced tools and services which lowers downthe initial development, installation, hosting, and
application running cost.Also, as thepatient records keep increasing with time,Cloudauto-scales
the storage avoiding applications falling into data storage failures.
One of the key features facilitated by EMRs with Cloud Computing is API integration.
EMRs with APIs provides continuous monitoring abilities along with high powered analytics.
Relevant information and custom plans can be generated by analyzing huge patient data sets.
Also, when integrated with hardware, these EMRs can record continuous data which can be later
analyzed to identify any underlying conditions or illness, facilitating early diagnosis. These EMR
systems are software-based applications and from an FDA standpoint, as they are utilized in a
health and medical setting, they should be FDA compliant before they are used in the industry.
Being a software system, these EMR applications may fall into the categories of Software
as a Medical Device (SAMD) or Software in a Medical Device (SIMD). In such cases,
manufacturers or software developers should sufficiently test and document their EMR systems
which validate if the system reaches the defined intended use. This is achieved by documenting
the system and software requirements along with the overall system architecture. For verification
and validation purposes, manufacturers should perform testing which may include unit, system,
integration, and acceptance testing along with the risk assessment which captures any safety-
1
Vinati KamaniArkenea (October 2019)5 Ways Cloud Computing is Impacting Healthcare. Retrieved on 24th
Nov ember 2020 from https://www.healthitoutcomes.com/doc/ways-cloud-computing-is-impacting-healthcare-
0001.

2. related risks present in the system. Also, when it comes to Cloud-based data, developers should
make sure they are using the latest data security frameworks to keep their hosted data secure.
Example: Selecting a Cloud platform that incorporates HIPAA (Health Insurance Portability and
Accountability Act) based data security.2 If the FDA observes that the system meets the required
quality, efficiency, security, and safety requirements, it provides the clearance to host or market
the Cloud-based EMR application.
To summarize, Cloud Computing is powering EMR systems and enhancing the online
patient documentation services to add elements such as universal remote access and data
scalability. With features such as API Integration and Analytics, these systems are adding an
overall quality to patient care. Surely, before these applications are released and utilized in the
medical industry, they should meet all FDA regulatory guidelines which ensure they meet the
required levels of safety and quality. Do you have a software product that may require FDA
clearanceorapproval? Ourregulatory andsoftwareexpertsatEMMAInternationalcanhelpyour
software application get FDA compliant. Contact us at 248-987-4497 or
info@emmainternational.com for additional information.
2
Rahul Varshneya (August 2019).How toEnsure That Your Cloud Hosted HealthcareData Is HIPAA Compliant.
Retrieved on 24th November 2020 from https://hostingjournalist.com/how-to-ensure-that-your-cloud-hosted-
healthcare-data-is-hipaa-compliant.