Policies – Page 4 – media

New blood pressure guidelines could put lives at risk, say experts

A new report in JAMA Internal Medicine by University of Sydney and Bond University scholars weighs the risks and benefits of a recent change to blood pressure guidelines in the US.
- Source: MedicalXpress
- 568
- April 17, 2018
blood pressure Policies
FDA to expand digital health pre-cert program by end of 2018

The FDA's Center for Devices and Radiological Health plans to expand its digital health pre-certification pilot program by the end of 2018, the center's associate director for digital health Bakul Patel said March 22, according to Regulatory Focus.
- Source: Beckers Hospital Review
- 663
- April 2, 2018
digital health FDA medical device Policies
Vanderbilt researcher says hospital data breaches are tied to patient deaths

The research compared patient care metrics at hospitals that had experienced a data breach and those that had not. For instance, the study examined the proportion of heart attack patients that die within 30 days of being admitted to a health system.
- Source: MedCityNews
- 593
- March 28, 2018
cybersecurity digital health Policies
Big Events on Pharmaceuticals during NPC & CPPCC

The two sessions (NPC & CPPCC) this year have received much attention from China and outside China, wherein, the most-watched theme is “reform”. Regarding pharmaceuticals, the event that attracts the highest attention is CFDA reform, followed by policy moves of the TCM issue and bio-medicine, etc. that China has been strongly supporting in recent years.
- Source: EN-CPhI
- 1,157
- March 26, 2018
CFDA China CPhI pharmaceutical Policies
NHS and digital health firms must improve cybersecurity

The NHS and digital health companies must learn from other industries to secure devices and systems against cyber attacks, according to a new report.
- Source: PharmaPhorum
- 708
- March 21, 2018
cybersecurity NHS Policies
CFDA Continues to Expand Oversea Inspection

On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good Manufacturing Practice.
- Source: drugdu
- 687
- March 14, 2018
CFDA medical device products Policies
FDA Orders Recall of Drug Dosage mHealth App for Diabetic Patients

The FDA has ordered the recall of a mHealth app that helps people with diabetes determine how much insulin they should inject. The issue points to the continuing challenge of verifying the accuracy of digital health devices and drug dosage apps.
- Source: mHealth Intelligence
- 784
- February 26, 2018
diabetes FDA mHealth Policies
Final FDA Rule Requires Medical Device Trials Outside US to Conform to GCP

The US Food and Drug Administration (FDA) on Tuesday finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards.
- Source: Regulatory Affairs Professionals Society
- 652
- February 24, 2018
FDA medical device Policies

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