Regulatory Standards & Certification Requirement - Headband to monitor mental health

T

Thukira

#1
Hello everyone;

Need clarification

We are planning to design a wearable device – a headband kind of thing, to monitor the mental health - fatigue/stress using the brainwaves (EEG). The system will have the metal electrodes making contact with the skin/hair on the forehead/parietal lobe, an analog front end amplifiers, DSP, wireless communication module and a rechargeable battery (Li-ion).

The device will be targeted for use in non-clinical setting. The industries we are targeting are Manufacturing, Mining and Oil & Gas.

Would like to understand from the regulatory perspective what are all the Standards/certifications we need to comply with for such a device.
 
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T

Thukira

#2
Re: Regulatory Standards & Certification Requirement - Headband to monitor mental hea

Hi again

Adding to my previous post

It is operated using Li battery of voltage less than 10V, and non-sterile intended to use in "no-clinical environment"

Firstly - will this be qualified as "medical device"
and it will not cover under LVD as voltage is out of range..

Can someone throw light on this please
 

QAengineer13

Quite Involved in Discussions
#3
Re: Regulatory Standards & Certification Requirement - Headband to monitor mental hea

Hi again

Adding to my previous post

It is operated using Li battery of voltage less than 10V, and non-sterile intended to use in "no-clinical environment"

Firstly - will this be qualified as "medical device"
and it will not cover under LVD as voltage is out of range..

Can someone throw light on this please
Thukir,

For the US market, I would recommend you reading this :Digital Health Criteria

Then, assess whether your device would fit in any of the digital health category , if it does...review all these guidance document based on your product applicability Guidances with Digital Health Content
 
T

Thukira

#4
Re: Regulatory Standards & Certification Requirement - Headband to monitor mental hea

Thanks for the advise regarding US markets;

But I'm looking out requirements for EU and Indian Markets; please guide
 
K

KevinMike

#5
Re: Regulatory Standards & Certification Requirement - Headband to monitor mental hea

Digital Health | Future of Healthcare Industry.

Changing regulations and patient demographics are persuading the healthcare industry to improve the quality of health services, organizational efficiency, and cost management. In such circumstances, healthcare providers need to address challenging issues such as, over or under treatment, misdiagnosis, unnecessary procedures/medication and delayed diagnosis.

Digital health is a cluster of emerging technologies and applications that leverage data, cloud, and mobile platforms for effective patient treatment. The utility of digital health extend to a wide range of health care processes ranging from monitoring patients in general wards, ICUs or at home, to assist physicians in making accurate and better diagnoses. Healthcare providers are now utilizing advanced digital tools to better understand their patients and treat them. Digital health is transforming patient care into a more convenient and responsive process coordinated with the patient’s need.
Digital health systems segment dominated the global market in 2016.

EHRs and e-prescriptions allow access to a more in-depth evaluation of patient records enabling physicians to reach to a more accurate diagnosis. In case of an emergency, EHR can provide critical and lifesaving information quickly to emergency care providers. E-prescriptions prevent handwriting errors and provide both physicians and pharmacists with easy access to prescription history of patients. This can largely help reduce the chances of dispensing wrong drugs. According to the FDA, medication errors harm approximately 1.3 million American citizens annually.

mHealth market will witness favorable growth over the forecast period as a result of increasing smartphone penetration worldwide and technological innovations in health based mobile applications.

North America held the largest share of the global digital health market in 2016, due to increased healthcare spending in the region, improved healthcare infrastructure, and rapid adoption of digital health technology. According to a study conducted by the National Center for Biotechnology Information in December 2015, more than half of the mobile phone users in the U.S. have downloaded a health related mobile app.

The Asia-Pacific digital health market will witness the fastest growth during the forecast period. Emphasis on integration of technology with healthcare and government initiatives to support digital health in emerging economies will drive the growth of digital health market in these countries. For example, in January 2016, the government of India launched a mobile health service ‘Kilkari’ under its Digital India initiative. This platform delivers weekly audio messages to expecting mothers educating them about pregnancy, child care, and child birth. Such initiatives are creating an ecosystem for favorable growth of digital health market in developing countries.

Product development and technological innovations steer the competitive digital health market. In 2017, Nokia expanded its digital health portfolio by launching the Withings brand of connected health products. It also announced the introduction of a HIPAA compliant Patient Care Platform which will assist doctors to remotely monitor their patients.
 
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