No fancy intro \u2014 let\u2019s just get right into this.<\/p>\n\n\n\n
Healthcare compliance is the process to meet all government rules and regulations imposed under several healthcare laws such as PHIPA, PIPEDA and HIPAA. <\/p>\n\n\n\n
Be it your healthcare app, software, website or any other clinical practice, when it works only according to the rules and regulations of applicable laws, it is called a healthcare compliant app or platform or clinical practice. <\/p>\n\n\n\n
For instance, if there is a requirement to ask permission of patients before storing their data on your healthcare mobile app, your app should have a feature that asks user permission and manages it. <\/p>\n\n\n\n
This is an example of one requirement. When your app follows all such requirements of the law, it becomes compliant with particular healthcare law. <\/p>\n\n\n\n
Because there are many different requirements under different healthcare laws. <\/p>\n\n\n\n
It depends on the region you are doing clinical practice or planning to launch the healthcare app\/platform.<\/p>\n\n\n\n
For instance, HIPAA healthcare law applies to your app and clinical practice in the USA. <\/p>\n\n\n\n
Same way, PIPEDA law applies to you at the federal level in Canada. <\/p>\n\n\n\n
There are many other laws imposed by the state governments and apply to you in different provinces or states. <\/p>\n\n\n\n
Such as PHIPA in Ontario, HIA in Alberta etc. <\/p>\n\n\n\n
Yes, government entities must also meet all healthcare rules and regulations. However, there are dedicated laws imposed for government entities. <\/p>\n\n\n\n
For instance, there are two such laws in Ontario – FIPPA and MFIPPA. <\/p>\n\n\n\n
\u201cFIPPA covers all ministries of the Ontario Government and any agency, board, commission, corporation or other body designated as an “institution” in the regulations.\u201d <\/p>\n\n\n\n
\u201cMFIPPA covers all municipal corporations, including a metropolitan, district or regional municipality, local boards and commissions.\u201d<\/p>\n\n\n\n
However, FIPPA is not healthcare-specific law. It protects the privacy of all individuals in Ontario including those who receive healthcare. <\/p>\n\n\n\n
Yes, regardless of the scale you\u2019re operating, every startup, healthcare provider and even business partner of these healthcare providers and startups that handle patient data should adhere to healthcare compliance. <\/p>\n\n\n\n
Here, there are two scenarios. <\/p>\n\n\n\n
No, you will be never asked by either a user or government to show the certificate that proves the compliance-readiness. Because there is no such certificate! <\/p>\n\n\n\n
However, it is advisable to keep all of your best practices of ensuring compliance-readiness well-documented. <\/p>\n\n\n\n
Because many laws including HIPAA ask you to have documented policies and procedures. <\/p>\n\n\n\n
You don\u2019t have to prove it actually. <\/p>\n\n\n\n
But yes, when a user lodges a complaint against your app or clinical practice at the Privacy Commissioner of Canada, they will ask you everything you do to ensure compliance readiness. <\/p>\n\n\n\n
You also need to prove compliance for getting funding from either investors or government agencies. <\/p>\n\n\n\n
If you\u2019re developing a SaaS healthcare platform, your customers will also ask you to present compliance-readiness. <\/p>\n\n\n\n
This is why we earlier told you to document all of your technical and business efforts that directly affect the compliance of your app or clinical practice. <\/p>\n\n\n\n
Or, you can hire a compliance consultant<\/u><\/span><\/a> that takes care of everything. He will work as the compliance certificate with his expertise and experience!\u00a0<\/p>\n\n\n\n Healthcare compliance is very important as it eliminates all the security issues out of the healthcare app\/software and makes sure all patient data is safe and secure. <\/p>\n\n\n\n And more importantly, if you violate it, you will be liable for the very hefty fine. <\/p>\n\n\n\n Particularly in Canada, there is no dedicated law forcing you to be compliant with healthcare laws. <\/p>\n\n\n\n However, each individual healthcare law asks defined entities to be compliant with it. <\/p>\n\n\n\n To keep patient data secure on your platform, to build trust among your users & investors and to keep yourself away from any legal trouble, it is a must to consider healthcare compliance. <\/p>\n\n\n\n If your healthcare mobile app, software or clinical practice does not adhere to applicable laws, you as the organization can be liable for a fine of up to $500,000 and even more. <\/p>\n\n\n\n Simply no. <\/p>\n\n\n\n These healthcare laws apply to your entire organization including staff, their devices such as mobile phones, laptops, your business partners and your physical assets including servers. <\/p>\n\n\n\n For instance, you have to hire a Security Officer or Privacy Officer. You have to make sure that no unauthorized users can access your physical servers. <\/p>\n\n\n\n You have to provide your staff with annual compliance training. You have to use healthcare compliant servers to host your app or data. <\/p>\n\n\n\n The following are the actionable steps. <\/p>\n\n\n\n Suppose you\u2019re developing a healthcare mobile app. <\/p>\n\n\n\n You should also carry out PIA (Privacy Impact Analysis) which validates the compliance-readiness of your entire organization. <\/p>\n\n\n\n Meaning, PIA makes your organization compliant with applicable laws and TRA makes your software or application compliant with applicable laws.<\/p>\n\n\n\nQuestion 9: Why is compliance important in healthcare?\u00a0<\/span><\/strong><\/h2>\n\n\n\n
Question 10: Is healthcare compliance mandatory?<\/span><\/strong>\u00a0<\/h2>\n\n\n\n
Question 11: Are only healthcare apps\/software need to be compliant with healthcare laws?\u00a0<\/span><\/strong><\/h2>\n\n\n\n
Question 12: How to be healthcare compliant?\u00a0<\/span><\/strong><\/h2>\n\n\n\n