Regulation for Health Care Software Programs: Part 2

http://www.jaame.or.jp/mdsi/261114.pdf

When we determine the applicability of programs within the scope of medical device, we have to take into consideration two elements:

(1) What contribution can the program provide to medical treatment, diagnosis, etc of disease?

(2) What is the likelihood of risk to human life and health if disorders arise in relation to said program?

The following examples are not within the scope of medical device:

1) A program which enables the date obtained from other medical devices to be transferred, stored and indicated for the purpose of diagnosis records.

For example:

a) Where the program does not contain the function to indicate date, rather enables the date from medical devices to be transferred to other programs etc without modification, apart from compression.

  1. Where the program enables the format of dates from medical devices to be changed and unified, etc for the purpose of indication and edits the information of patients and the report of examination for diagnosis records.
  2. Where the program enables images captured by graphic diagnosis devices (such as CT) to be transferred, stored and indicated for the purpose of diagnosis records.
  3. Where the program enables the reports of each patient to be stored and managed continually by input, indicating the item of examination.
  4. Where the program enables parameter data such as the names and ID of patients to be transferred etc. without modification of such data.

2) A program which enables the date, excluding image, to be modified and applied (except for the purposes of diagnosis)

For example:

  1. Where the program enables the date obtained from medical devices to be modified and applied to be indicated via computer (except where the program to read via computer the date from CPAP device using SD card and create chart)
  2. Where the program is used to create graphs indicating data and store said data.
  3. Where the program is used for statistic processes such as locating significant difference etc.

3) Educational programs

For example:

  1. Where the program is designed for the purposed of training medical persons
  2. Where the program enables the transfer of live information from the surgery room to be displayed as video outside of the surgery room.

4) Program used for the purpose of giving explanations to patients

For example:

  1. Where the program is used to facilitate doctors or other persons to explain surgery etc. to patients using animation and image

5) Programs used for maintenance purposes

For example:

  1. Where the program enables the information concerning the timing of change consumable goods and maintenance to be check, transferred, recorded and indicated
  2. Where the program to checks the performance and the history of processes automatically
  3. Where the program records and indicates information such as: performance history, serial ID, ID of the person in charge etc.

6) Programs for the purpose of supporting internal activity within the hospital

For example:

  1. Where the program is used for the purposes of making internet reservations for diagnosis
  2. Where the program assists internal processes in relation to clinical data collection by printing out the data, accommodating the patients and calculating itemized statements of medical expenses.
  3. Where the program enables the management of sale of the medical devices, the management of stock, the record of entering and dispatching etc.
  4. Where the program enables recording and indication of appended paper in relation to medical devices in order to manage integrally the appended papers of medical devices.

7) Health Care Programs

For example:

  1. Where the program which enables parameters for health conditions such as weight, blood pressure, heart beat, and blood glucose level, to be indicated, transferred and recorded for daily management of health.
  2. Where the program which enables the date from medical devices such as the electronic measure of blood pressure to be transferred, indicated, graphed and recorded for personal record.
  3. Where the program enables medicinal information and child health handbook records to be shown partially or totally, in order to manage the history of taking medicine, history of health for mothers and children.
  4. Where the program enables the personal health history to be shared with service providers for the management of health (limited to the non diagnosis purpose).
  5. Where the program enables home appliances to be controlled using censors in order to improve the environment of daily life.
  6. Where the program provides a menu for the improvement of daily life as well as other advice using censor detected personal health information, such as calculation of the walking steps in order to improve physical condition.
  7. Where the program enables the diagnosis datato be managed and the health check reports to be prepared for the sake of health examination.
  8. Where the program enables the result of health examination to be input, recorded, managed and provided in graph format.
  9. Where the program enables the data to be prepared for the purpose of health preservation.
  10. Where the program is used to discover variations in health preservation advice determined by academic association for the purpose of improving daily life practices.

8) Programs equal to general medical devices (where there is no influence on human life and health even in the case of device malfunction), which have been excluded from the scope of medical device by order of enforcement.

For example:

  1. Where the program is used to examine the visibility of eye and color sense via general computer and portable device.
  2. Where the program enables detection of body movements using censor of portable devices.
  3. Where the program supports the allocation medicines by giving notice of appended paper and guidelines etc.

The above mentioned information is for summary purposes only. Please seek professional advice for further information.