InvestorsHub Logo

Doc328

10/11/19 12:31 PM

#214082 RE: XenaLives #214080

The TGA does not have access to clinical study data for any specific patient. Australia is not some dystopic society where the state controls and knows all. The EHR is for patients, providers and hospitals/healthcare systems, not the regulatory state agencies. Currently no data is shared with the state and in the future only de-identified data may be shared (if patients opt in).


Austrlian Myhealth EHR

Using data from your record for research
De-identified data from your record may be used for research purposes. This data informs policy making decisions to help improve Australia’s health system and provide better healthcare for Australians.

De-identified data is health information that is not connected to your identity.

No data will be shared with any third parties until the framework is finalised in 2020.

JWC3

10/11/19 12:35 PM

#214083 RE: XenaLives #214080

The primary focus of Dr. Missling’s current visit to Australia is AD results and progress. So the initial Provisional Approval could be limited to AD and just focusing on the already available 4 years of spectacular data. The as the data becomes available in the next 2-3 months, as the initial Rett Trial data just did, then the additional approvals would be immediate for Retts and PDD!