Key Regulatory Compliance Standards Healthcare Software Developers Know That

1
Key Regulatory Compliance Standards That
Healthcare Software Developers Should Know About
2
It is not easy to build healthcare software from
scratch. It takes a lot of work to ensure that
the software runs smoothly and meets all
compliance requirements. This is where many
custom healthcare software development projects
fall apart. Compliance with regulations is
something that should not be taken lightly.
Non-compliance with data security regulations is
a serious matter. Companies responsible will be
punished harshly. A healthcare software provider
was hit with a staggering 1.5 million fine by
French data protection authorities. Penalties for
security violations by healthcare companies in
the USA can reach up to 1.5million. The devil
is always in details. And the finer points of
regulations can get you into trouble.
3
What are Regulatory Compliances for Healthcare
Products?

• The healthcare industry is governed by
  regulations, just like any other industry. These
  regulations determine what is legal or
  illegal.Each country has its own regulations
  that the healthcare industry must follow when
  implementing healthcare software solutions. Below
  are some of the most important regulations.
• Health Insurance Portability and Accountability
  Act, (HIPAA)-USA
• Federal Food, Drug, and Cosmetic Act (FFDCA-USA)
• Food and Drug Administration (FDA), USA
• Health Information Technology for Economic and
  Clinical Health Act - USA
• Office of the Australian Information Commissioner
  (OAIC), Australia
• Personal Information Protection and Electronic
  Documents Act, Canada
• General Data Protection Regulation (GDPR), The
  European Union -European Union

4
Why Is It Essential to Follow Regulatory
Compliance in Healthcare Software and App
Development?
Privacy Data Security
Privacy and data security are the main concerns
when it comes to healthcare software
development. Cyber attacks are constantly
threatening the digital world. Naturally,
healthcare solutions can also be at risk. Digital
storage is used to store sensitive information
that patients share with their healthcare
providers. This software often uses cloud
computing technology to function. These
cyberspaces are vulnerable to data theft and
attacks.
5
Patient-Centric Care
These regulations do not just protect data but
are part of an overall effort toward making
healthcare more patient-centric. These
regulations require that the healthcare IT
provider puts the patient's interests first and
takes every precaution to avoid any missteps. It
also prevents fraud in the healthcare system by
ensuring that no patient is exploited by big
business. Data protection, in conjunction with
the previous point, protects patients from any
emotional harm that identity theft or data loss
can cause.
6
Avoid Fines and financial losses
Sometimes, the price of not following government
regulations can be too high. This is a serious
matter that should not be overlooked. If the
software is not in compliance with regulations,
fines can reach 1.5 million. If these
precautions are not taken, healthcare service
providers can suffer severe losses. Healthcare
providers could fall for cyber-tricks such as
data breaches and holding data hostage for
ransom.
7
Regulatory Approval
You cannot make your software product work in the
public sector if it doesn't have the approval of
these regulatory bodies. It is impossible to move
forward without a certificate of conformity.
These problems can only be solved by updated
regulations. These are just a few of the
compliance reasons. Let's take a look at the
compliance requirements for healthcare software
developers.
8
Regulatory Compliances for Healthtech Products in
Different Countries
Numerous regulations are enforced in the
healthcare sector. It is not a deterrent but a
means to better services and benefits for
everyone. These are some of the most important
FFDCAUSA
Medical devices are governed by the Federal Food,
Drug, and Cosmetic Act. This includes healthcare
software, pharmaceuticals, and many other
products. Before obtaining compliance with the
FFDCA, you must first meet several approvals such
as the PMA (Pre-Market Approval), Pre-Cert
Program(Digital Health Software Pre-Certification
Program), SaMD Software as a Medical Device,
and the LDT (Laboratory Developed Test).
9
HIPAAUSA
The 1996 Health Insurance Portability and
Accountability Act (HIPAA) outlines the
guidelines one must follow in order to collect,
store and transfer personal data from customers.
Healthcare facilities that fail to comply can be
sued. You must comply with HIPAA regulations if
your software involves PHI (protected healthcare
information), EMRs, or EHRs (electronic records
of medical records)
HITECH Act -USA
To promote meaningful use and adoption of health
information technology, the HITECH Act (Health
Information Technology for Economic and Clinical)
was created. This law requires healthcare
providers to adhere to HIPAA regulations.
10
Food and Drug Administration (FDA)
Each software application and every standalone
device that is intended for mass use must be
subject to the strict scrutiny of the FDA, and
the United States Department of Health and Human
Services. The FDA reviews the software to ensure
compliance with regulations before approving its
use and distribution to the public.
OAICAustralia
The OAIC, or Office of the Australian Information
Commissioner, manages regulations pertaining to
the distribution and use of software and
healthcare technologies. It outlines how personal
information about patients is collected and
stored. Patients have full control of sensitive
data. In the event of data breaches, healthcare
providers must provide complete network security
and reports immediately.
11
PIPEDACanada
Personal Information Protection and Electronic
Documents Act,2000 (PIPEDA), governs personal
information that businesses use for commercial
purposes. Although it is similar to HIPAA in many
respects, it also provides data protection for
medical applications. For each violation, it can
impose a maximum of 100,000.
General Data Protection Regulation (GDPR)-The
European Union
It is generally valid within the European Union.
The GDPR expands the scope of sensitive data in
comparison to other regulatory bodies. This
includes biometric data and genetic data as well
as IP addresses and data on racial, ethnic
origin, and religion. Individuals have the right
to withdraw their consent at any time.
12
Conclusion
Before the product is launched, compliance with
regulations and custom healthcare app development
must first be considered. It's better to know and
follow the regulations than to face financial
loss and legal action from the government. You
must verify that they are not in violation of the
regulations or have been subject to legal action
before you hire them.Here in this blog you can
find all Key Regulatory Compliance Standards That
Healthcare Software Developers Should Know and
follow while developing a healthcare software .
To know more about kindly request a free quote at
EMed HealthTech
13
www.emedhealthtech.com
079 48001671
info_at_emedhealthtech.com