HDx Cognition

US

UK

Pay as You Go

Starter

Growth

Enterprise

The assessment consists of a battery of cognitive tests. Technical supervision is advised, and practices can deploy with any healthcare provider, including medical assistants or technicians to supervise.

Powerful cloud-based software analyzes the inputs, scores the tests, and compares them against healthy norms that have been validated in our clinical trials. Then the proprietary algorithms analyze results and map them onto cognitive domains.

Longitudinal tracking is included in reports at both the individual test level, and as cognitive domains. Reports can be exported and appended to the EHR for clinical assessment and review and/or downloaded to your device for later review. The platform is accessible anytime, anywhere by approved and registered users.

One click populates your patient’s test protocol with the predefined 35-45 minute cognitive assessment, consisting of well-established cognitive tests such as TMT A&B, ROCFT, and RAVLT. Commonly used questionnaires for depression and anxiety and add-on tests relevant for dementia and MS patients are also available to use when needed.

Normative data across age, sex and education was collected in the US in two clinical trials in 2019 and 2021 as part of a monitored clinical trial of healthy people representative of the US population between ages of 18-88. Allows for an accurate comparison between patients and a healthy peer population.

Using validated algorithms validated against expert manual scoring, HDx Cognition delivers accurate, repeatable, and reproducible results. Results include domain-specific scores, normative comparisons, historical tracking, and downloadable PDFs for seamless electronic health record integration.

Interactive dashboards allow clinicians to monitor cognitive function across multiple time points, view trends by domain or test, and drill down into detailed cognitive performance changes.

HDx Cognition Platform is fully reimbursable in the United States using a combination of Current Procedural Terminology (CPT) coding. [only applies to US]

CPT Code¹	Description¹	Estimated Reimbursement²
96132	Neuropsychological testing evaluation services by physician or other qualified health care professional, including integration of patient data interpretation of standardized test results and clinical data, clinical decision making, treatment planning and report, and interactive feed back to the patient, family member(s) or caregiver(s), when performed; first hour	$128.12
96133	Neuropsychological testing evaluation services by physician or other qualified health care professional, including integration of patient data interpretation of standardized test results and clinical data, clinical decision making, treatment planning and report, and interactive feed back to the patient, family member(s) or caregiver(s), when performed; each additional hour	$97.17
96136	Psychological or neuropsychological test administration and scoring by physician or other qualified health care professional, two or more tests, any method; first 30 minutes	$41.60
96137	Psychological or neuropsychological test administration and scoring by physician or other qualified health care professional, two or more tests, any method; each additional 30 minutes	$37.60
96138	Psychological or neuropsychological test administration and scoring by technician, two or more tests, any method; first 30 minutes	$34.28
96139	Psychological or neuropsychological test administration and scoring by technician, two or more tests, any method; each additional 30 minutes	$35.28

Source:

Note:

The information provided is intended to assist providers in determining appropriate codes and reimbursement purposes. It represents the information available in the public domain at the time this document was produced. It is the provider’s responsibility to determine and submit appropriate codes, modifiers, and claims for the services rendered. Before filing any claims, providers should verify current requirements and policies with the applicable payer. Head Diagnostics makes no guarantees concerning reimbursement or coverage. Actual payment rates may vary by geographic region and specific practices; therefore, actual payment rates may differ from those reflected in the table above, which is sourced from the American Academy of Neurology’s summary of Medicare 2024 Physician Fee Schedule.

Time Interval	CPT Code(s)^3,4
16-45 min	96138
46-75 min	96138 + 96139
76-105 min	96138 + (96139 × 2)
106-135 min	96138 + (96139 × 3)

For time-based codes, a unit of time is attained when the mid-point is passed– thus, for 1 hour interval codes, 31 min need to have passed to bill the codes^3,4

Sources:

3. APA, “Getting Reimbursed: Testing Code Changes are Here”

4. APA, "Up to Code: Testing Code Changes are Here"

Time Interval	CPT Code(s)^3,4
31-90 min	96132
91-150 min	96132 + 96133
151-210 min	96132 + (96133 × 2)
211-270 min	96132 + (96133 × 3)

For time-based codes, a unit of time is attained when the mid-point is passed– thus, for 1 hour interval codes, 31 min need to have passed to bill the codes^3,4

Sources:

3. APA, “Getting Reimbursed: Testing Code Changes are Here”

4. APA, "Up to Code: Testing Code Changes are Here"

HDx Cognition is compatible with the following devices. These devices are supplied and configured by the customer. Ensure that the hardware for the HDx Cognition Demo application complies with the specifications documented in this section. Head Diagnostics provides both minimum and recommended specifications for each piece of hardware. Hardware specifications can be equivalent or better than those listed. Performance has been found acceptable when using the specified hardware.

Model	Release Date	Min. iOS version	Min. capacity
iPad Pro (3rd Generation) 12.9 inch, Wi-Fi (+ optionally cellular)	November 7, 2018	16	64 GB
iPad Pro (4th Generation) 12.9 inch, Wi-Fi (+ optionally cellular)	March 25, 2020	16	128 GB
iPad Pro (5th Generation) 12.9 inch, Wi-Fi (+ optionally cellular)	March 25, 2021	16	128 GB
iPad Pro (6th Generation) 12.9 inch, Wi-Fi (+ optionally cellular)	October 26, 2022	17.5	128 GB
iPad Pro (7th Generation) 13 inch, Wi-Fi (+ optionally cellular)	May 15, 2024	17.5	256 GB
iPad Air (6th Generation) 13 inch, WiFi (+ optionally Cellular)	May 15, 2024	18.3	128 GB
iPad Air (7th Generation) 13 inch, WiFi (+ optionally Cellular)	March 12, 2025	18.3	128 GB

Model	Release Date
Apple Pencil (2nd Generation)	November 7, 2018
Apple Pencil Pro	May 7, 2024
Apple Pencil USB-C	November 1, 2023

Platform	Operating System	Browser
Windows	Windows 10, Windows 11	Chrome
Mac	OSX 13.0 or higher	Chrome preferred, Safari

Hardware	Recommend
Processor	2.5 Ghz
Screen Resolution	Minimum: 1024 x 768
RAM	8 GB

Type	Requirement
Internet speed	Each connected iPad Pro and computer requires a stable Wi-Fi and internet connection of at least 5 Mbps
Ports	Port 443 of the Philips cloud should be accessible from the iPad Pro and computer
App Store	The iPad Pro should be able to download and install the TestFlight and HDx Cognition application from the Apple App Store

To access the HDx Cognition web application on a laptop or desktop the following address should be used in the address bar of the web browser:

USA: https://hdc.us.headdiagnostics.com
UK: https://hdc.uk.headdiagnostics.com

If there are issues while trying to access the HDx Cognition web application please ensure your IT department has allowed your internet installation to perform the correct DNS resolution for the following addresses:

USA: https://hdc.us.headdiagnostics.com
UK: https://hdc.uk.headdiagnostics.com

Judge D, Roberts J, Khandker RK, Ambegaonkar B, Black CM. Physician practice patterns associated with diagnostic evaluation of patients with suspected mild cognitive impairment and Alzheimer’s disease. Int J Alzheimers Dis. 2019;2019:4942562. https://pmc.ncbi.nlm.nih.gov/articles/PMC6415302/
Biggin F, Howcroft T, Davies Q, Knight J, Emsley HCA. Variation in waiting times by diagnostic category: an observational study of 1,951 referrals to a neurology outpatient clinic. BMJ Neurol Open. 2021. https://pmc.ncbi.nlm.nih.gov/articles/PMC8183200/
Chodosh J, Petitti DB, Elliott M, et al. Physician recognition of cognitive impairment: evaluating the need for improvement. J Am Geriatr Soc. 2004;52(7):1051–1059. https://doi.org/10.1111/j.1532-5415.2004.52301.x · Lang L, Clifford A, Wei L, et al. Prevalence and determinants of undetected dementia in the community: systematic review and meta-analysis. BMJ Open. 2017;7(2):e011146. https://doi.org/10.1136/bmjopen-2016-011146
Based on a 2019 Philips study of 100 US neurologists. Philips press release, 12 Nov 2019.
How cognitive profiles can assist the differential diagnosis of dementia

Can I use any tablet for HDx Cognition?

HDx Cognition runs on a compatible iPad Pro 13" or iPad Air 13" used with an Apple Pencil. A complete, up-to-date list of supported devices is provided in the User Guide.

A tablet is not required to view a report or previously collected data — these can be viewed in the web application on any PC using Chrome (preferred) or Safari.

Is HDx Cognition scientifically validated?

Yes. HDx Cognition has undergone significant validation to demonstrate that it performs as intended, including:

A monitored clinical trial comparing digital and paper-based test performance.
A comparison of HDx Cognition's algorithm scoring output against appropriately qualified scorers of neuropsychological tests.
Usability validation carried out in accordance with internationally recognised human factors and usability engineering standards, including IEC 62366-1:2015.

The supporting rationale and evidence are documented within the technical documentation for the device. HDx Cognition includes normative data appropriate to its intended use, and the paper-based tests on which it is based are supported by peer-reviewed literature.

How frequently can I assess a patient with HDx Cognition?

You can assess a patient as often as is clinically appropriate. Some tests may be subject to learning effects, so this should be taken into account when interpreting repeat assessments. If a perceived improvement in cognition may be due to a learning effect, we recommend consulting a neuropsychologist.

Which disease groups can I assess with HDx Cognition?

In principle, HDx Cognition may be used wherever cognitive assessment is clinically appropriate, subject to the intended use. A healthcare professional (HCP) should be present to ensure accurate data collection and should intervene whenever the level of impairment prevents the person from performing the tests.

Who is qualified to use HDx Cognition?

Any appropriately qualified HCP who has completed the mandatory HDx Cognition training may use HDx Cognition. The assessment and tests are designed so that the patient can perform them under minimal supervision by a technician or assistant, in line with the training and intended-use documentation.

Is my data maintained by HDx Cognition in a safe and secure way?

Yes. Data is stored in a secure cloud environment, hosted on Amazon Web Services (AWS), where Head Diagnostics manages and maintains patient information for its digital services and products. Head Diagnostics has implemented robust technical and organisational measures to protect personal data against accidental or unlawful destruction, loss, alteration, unauthorised disclosure, or access, and operates in alignment with the applicable data-protection requirements of the jurisdictions in which HDx Cognition is offered. Our accreditations include HIPAA, GDPR, SOC 2, ISO 13485, ISO 27001, and Head Diagnostics is FDA and MHRA Registered.

What happens to the data collected with HDx Cognition?

The primary use of HDx Cognition, as described in detail in the Help tab of the application, is to provide the HCP with a cognitive overview of the patient. HDx Cognition is hosted on Amazon Web Services (AWS); the Healthcare Provider acts as the controlling party for the patient data (data controller / covered entity), and Head Diagnostics acts as the processing party (data processor / business associate), as applicable under the data-protection laws of the relevant jurisdiction.

Head Diagnostics must not access patient data other than for this primary purpose, unless required by law or an applicable regulatory obligation such as post-market surveillance, or where data is collected as part of a clinical study and the patient has given written consent for it to be shared. In the latter case, a data-sharing agreement between Head Diagnostics and the legal entity collecting the data must also be in place. For more detail, see the Privacy and Security section of the User Guide.

What is an assessment?

Within HDx Cognition, an assessment is a collection of cognitive tests performed in one sitting. A predefined battery of tests is available in the application and should be used when a cognitive overview of the patient — based on the HDx Cognition Cognitive Model — is required. You can also create your own selection of tests from those in the standard cognitive assessment, as well as the Category Fluency Test, Symbol Number Matching Test, and screeners (MMSE-2, GAD-7 and PHQ-9) that support clinical work-up.

Can I use HDx Cognition for longitudinal tracking?

Yes. The HDx Cognition report provides longitudinal results per test and per cognitive domain (the current assessment plus three previous assessments).

What is included in an HDx Cognition cognitive assessment?

The Cognitive assessment includes the following tests e.g. RAVLT, Trail Making Test, Star Cancellation Test, Letter Fluency Test and the Digit Span Test etc. For more information, select Help, then Test information in the application.

Can I change the HDx Cognition assessment test battery? Or Can I select single tests?

No — the predefined test order of the cognitive assessment cannot be changed. The HCP can select tests individually, but must acknowledge that doing so deviates from the standard cognitive assessment and that the Cognitive overview is not provided.

How much does an assessment cost?

Pricing ranges from a pay-as-you-go option to monthly subscription plans. When a report is generated, one assessment is counted against your monthly allotment, regardless of how many tests were included in it. Monthly subscription fees are invoiced at the start of each month; unused assessments cannot be carried over. For pay-as-you-go, billing occurs at the end of the month for the assessments used, at the listed price per assessment. Payment is due within 30 days of the invoice date, and the plan continues until cancelled by either party.

Can I change my plan?

Yes — to change your pricing plan, please contact customer service or your HDx Cognition representative or email at hdxcognition@headdiagnostics.com

Will I be reimbursed?

Reimbursement and funding arrangements vary by country, care setting, and local policy. Where applicable, recognised billing codes for cognitive assessment may be used. We recommend that your billing, finance, or commissioning team establish the appropriate procedures for your setting.

What happens if I use more assessments than are included in my plan?

Assessments performed above your plan's included volume are billed at the per-assessment rate for your chosen plan.

I want to cancel my plan, is that possible?

Yes. You can stop using HDx Cognition at any time, effective the following month. Payment is expected for any assessment quantities you have committed to and will not be refunded; additional assessments will not be billed. To close your account, please email hdxcognition@headdiagnostics.com

How do I contact HDx Cognition customer service?

If you have an issue while using HDx Cognition, we suggest first referring to the Help section in the application. If you can't find an answer, contact Head Diagnostics at hdxcognition@headdiagnostics.com

		Coverage Hours
Technical Support Services	Remote Support	7AM–10AM GMT
	Emergency (Level 1, 2)	7AM–5PM GMT
	E-mail response time	24 hrs
Maintenance	Software Updates & Upgrades performed by Customer	✓
Professional Services	On-Site education	Can be purchased as additional service days.

Clause	Module 2 – Selection
Clause 7 (Docking Clause)	Not applicable
Clause 11 (Redress)	Not applicable
Clause 9a (Prior Authorisation or General Authorisation)	Option 2 – General Authorisation
Clause 9a (Time period)	5 business days
Clause 17	Option 1 – The laws of the Member State of Ireland
Clause 18	The Member State is Ireland

Clause	Module 2 – Selection
Clause 7 (Docking Clause)	Not applicable
Clause 11 (Redress)	Not applicable
Clause 9a (Prior Authorisation or General Authorisation)	Option 2 – General Authorisation
Clause 9a (Time period)	5 business days
Clause 17	Option 1 – The laws of the Member State of Ireland
Clause 18	The Member State is Ireland

For Customer	For Head Diagnostics
Signature	Signature
Printed Name	Printed Name
Address	Address Suite 3, One Earlsfort Centre, Lower Hatch Street, Dublin 2, Ireland
Position	Position
Contact person’s contact details	Contact person’s contact details
Date	Date
Role ☒ Controller ☐ Processor	Role ☐ Controller ☒ Processor
Data Exporter / Data Protection Officer Details	Data Importer / Data Protection Officer Details Head Diagnostics
Activities relevant to the data transferred under these Clauses: Processing of Personal Data in connection with the provision of the Services under the Agreement.

*Categories of data subjects whose personal data is transferred:*	☒ Customers and clients ☒ Customer’s employees, partners and vendors ☒ Customer’s clients, employees, vendors, and other data subjects where relevant and/or required in the provision of professional services to Customer
*Categories of personal data transferred:*	☐ Advertising/Marketing Data ☒ Contact Data (including Names, Address, Email, Phone, etc.) ☐ Demographic Data ☐ Device Data ☒ User Data ☐ Coarse Location (Zip Code or Higher) ☐ Online or Other Account Data ☒ Professional, School, or Work Data ☐ Public Data (from governmental public records) ☒ User Input Data (Information inputted or uploaded by users) ☐ Other Data (Describe):________________________________
Sensitive data transferred (if applicable) and applied restrictions or safeguards that fully take into consideration the nature of the data and the risks involved, such as for instance strict purpose limitation, access restrictions (including access only for staff having followed specialised training), keeping a record of access to the data, restrictions for onward transfers or additional security measures:	Is sensitive data transferred? ☒ Yes ☐ No If yes, please complete – what type of sensitive information? ☐ Biometric Data ☐ Non-Public Criminal History ☐ Financial Data ☐ Governmental Identifiers ☒ Health and Medical Data ☐ Data about Children ☐ Precise Geo-Location ☐ Political, Religious, Union Beliefs ☐ Race / Ethnic Origin ☐ Sexual Orientation In relation to the safeguards implemented to protect such sensitive data please see Exhibit A above.
*The frequency of the transfer (e.g. whether the data is transferred on a one-off or continuous basis):*	☐ One-off ☒ Continuous
*Nature of the processing:*	As set out in this Agreement.
*Purpose(s) of the data transfer and further processing:*	To provide the Services pursuant to the Agreement As further specified in the Order Form(s) and/or Service Level Agreement between the Parties As further instructed by Customer ☐ Other (Describe):____________________
*The period for which the personal data will be retained, or, if that is not possible, the criteria used to determine that period:*
*For transfers to (sub-) processors, also specify subject matter, nature and duration of the processing:*	Same as above.

35 – 45 minute digital cognitive battery comprised of well established cognitive tests

Objective, validated results based on existing and well-known paper-based tests

Longitudinal tracking cognitive performance across 6 domains of the brain

19 clinically validated tests, can be taken individually or as part of the HDx Cognitive Assessment battery

All tests are normed on age, sex and education

Reimbursable in USA

Gaining access to the right cognitive insights at the right time can be challenging and time-consuming

But with the accelerated, clinically validated, easy-to-read results of HDx Cognition…

Our customers agree – HDx Cognition works for them and their patients

How It Works

iPad or iPad Air

Download

US

UK

Plan

Patient performs assessment on a tablet

Input is scored and presented as results

Results inform and support identification earlier

Key Features

Assessments Comprised of Well-Established Cognitive Tests

Normed for Current US Demographic

Accelerated Scoring with Consistent Algorithms

Track Results Cognitive Change Over Time

Reimbursement

Technical Requirements

Infrastructure Requirements

Downloads & References

Frequently Asked Questions

Connectivity

Validation, normative data and intended use

Privacy and Security

Functionality

Pricing and Payment

Customer Service

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