Confusion between Software Medical Device and Health Software to do a QM

thisby_

Involved In Discussions
#1
Hello everybody! :)

I am currently helping a company to write the Quality Manual (kind of a stage). This company develops software to use in health care environments, a kind of EHR.
There is a particular part in the Quality Manual, the 7th part , regarding Design and development process particularly risk management and software safety classification which, according to the 13485 can be achieved by the 62304 part 5th (sw development process) that we are doing now.
We know that our product is not only a medical device, it can also be regular software. We read some standards about health software (HS), but is not clear for us, which kind of software can be considered so. I was hoping you could help me. (standards studied for HS: ISO/TS 29321:2008, ISO/TS 29322:2008, ISO/TR 27809:2007 and ISO/TS 25238:2007)
We are using the classification given by the 62304 regarding safety. We want to add classes to it, to insert regular software and maybe health software. The risk analysis for health software according to 29321 is almost the same as 14971, so before dive in this issue I really wanted to give some inputs about HS.
As you know, an EHR is an enormous box with so many lithe boxes inside (patient scheduling, patient information, office dashboard, scheduling, ADT, medical report, medical records, electronic prescription, billing…) all of them can be inserted inside the MD software, regular Sw or health software, so different assessments need to be made.
I appreciate all inputs!

Thank you in advanced,
Emilia
 
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Marcelo

Inactive Registered Visitor
#2
Re: Confusion between sofware medical device and health software to do a QM!

You seem to imply that your software is a medical device software and a healthcare software at the same time. If this is the case, i find this strange, because definitions and standards for medical device software and health software generally exclude one another.

Just using an example, standards for health software often say that these standards are not applicable to software which is:
* necessary for the proper application of a medical device or
* an accessory to a medical device or
* a medical device in its own right.

These last ones are medical device software.

Even if your software is really "both" (and it really can be both, depending on your intented use of the software) what i think you need to do is just this: define the intented use of the softwatre, including inside the system or other software, and them see which regulations/standards would apply to them. Maybe you will need to apply all regulations if the software fits in more than one type.
 
Last edited:

thisby_

Involved In Discussions
#3
Re: Confusion between sofware medical device and health software to do a QM!

Thank you Marcelo, I think I didn’t explain myself, I am sorry!
I wanted to say that, the software made by this company can be divided in sub products, some medical devices other maybe health software, other regular software, however we want the quality manual as general as possible to adapt to all this kind of products. The big problem is that according to the definition of Health Software is difficult to decide whether a software is health software or general software.
According to the definition of Health Sw from 29322:2008 is “software product for use in the health sector for health related purposes”. Maybe I have this problem because I can’t understand the meaning of health related purposes. Can anyone help me?
Thank you!
Emilia
 

Marcelo

Inactive Registered Visitor
#4
I understand you being confused because this definition seems too broad.

You´re trying to differentiate between medical evice software, healthcare software and "general" software". This general software would be software used in the healthcare sector but not for health related porposes.

What is a health related purpose? I don´t know, and i´m almost sure there´s no definition in the standards for those. There could be definitions in regulations, or at least you could exclude based on the definitions for other purposes (for example, the medical devic case cited before).

So, trying to build a hierarchy, lets say that:

1 - if the software is necessary for the proper application of a medical device or an accessory to a medical device or a medical device in its own right, it´s a medical device software.

2 - if it´s used in the healthcare sector and is not a medical device software, but it´s intented use is somehow related to the "process" of healthcare (another way of thinking is that it could impact the health of the patient), for example, a health record (note that this can be tricky sometimes, but i do not see other way of defining it).

3 - if it´s used in the healthcare sector, does not fit in the two above (not a medical device and not used in the "process" of healthcare), it´s a general software. Exempl,es in my point of view, would be a word processing software used to record information not related to healthcare process (anything from patient home address to financial reports of a hospital), software used for controlling the secutiry system of a hospital or clinic, etc. Again, anything which might not impact the health of the patient.

Please note that, in this line of thought, any software which is part of another software/system which, in turn, fits in one of the porposes above, should be treated in the same category.

Well, this is just a little brainstorm on the subject, not sure if it helped.
 
B

bobbt

#5
Re: Confusion between sofware medical device and health software to do a QM!

Thank you Marcelo, I think I didn’t explain myself, I am sorry!
I wanted to say that, the software made by this company can be divided in sub products, some medical devices other maybe health software, other regular software, however we want the quality manual as general as possible to adapt to all this kind of products. The big problem is that according to the definition of Health Software is difficult to decide whether a software is health software or general software.
According to the definition of Health Sw from 29322:2008 is “software product for use in the health sector for health related purposes”. Maybe I have this problem because I can’t understand the meaning of health related purposes. Can anyone help me?
Thank you!
Emilia
I want to point out that and identify that there are two harmonized standards for software, what I have found out is if you decide to be compliant to the 2nd edition of 60601-1 then the applicable sofware
stanadard is en 60601-1-4 IF you are complying to the 3rd edition of 60601-1 then you need to comply with EN 62304 for software. Cenelec
has an excellent website about when collateral standards can be used
in a simple nut shell one has till sometime between 2011 AND JUNE 1 2012
to comply to the 3rd ediion of 60601-1 standard, also the harmonized stanadrds directive dated 7/15/09 it will show that both standards for software are ok to use the same applies to the usablity standards as well
 
S

sfurlani

#6
I know you're in Italy, but perhaps this will be of help.

If a failure of the software would result in direct or indirect (through presenting the wrong information to the doctor) harm to the patient, then I would use the strictest of the standards. (FDA Class II Medical device)

Other software used in the healthcare industry (such as billing or scheduling) would be subject to other rules here in the States (HIPAA).

General software would likely be stuff like word editors.

Hope that helps,

-Stephen
 
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