May 17, 2020

A number of public health and medical groups have filed a lawsuit against the FDA

healthcare
USA
smoking
Catherine Sturman
3 min
e-cigarette (Getty Images)
Seven public health and medical groups, including Campaign for Tobacco-Free Kids, and several individual paediatricians havefiled a lawsuitin federal co...

Seven public health and medical groups, including Campaign for Tobacco-Free Kids, and several individual paediatricians have filed a lawsuit in federal court in Maryland, challenging the US Food and Drug Administration’s (FDA’s) decision which allows electronic cigarettes and cigars – including candy-flavoured products which appeal to children – to stay on the market for years without being reviewed by the agency.

The lawsuit was filed by the American Academy of Paediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five individual paediatricians.

Whilst the groups strongly support the FDA's efforts to reduce nicotine levels in cigarettes to non-addictive levels, they also believe that the FDA's August 2017 decision to exempt e-cigarettes and cigars from agency review for years to come is unlawful and harms public health.

The lawsuit contends that the FDA's decision to leave on the market tobacco products that appeal to kids, deprives the FDA and the public of critical information about the health impact of products already on the market, and relieves manufacturers of the burden to produce scientific evidence that their products have any public health benefit.

According to the lawsuit, the FDA's decision to delay product reviews leaves young people more vulnerable to kid-friendly e-cigarettes and cigars which may lead to a lifetime of tobacco addiction. An FDA review "should remove from the commercial marketplace those tobacco products that pose the greatest health risks, particularly those targeted at children and teenagers.”

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In addition, the FDA's decision not to annually review such products "will hinder the development of science needed to understand, and to educate the public about which products actually do promote smoking cessation and how they can be marketed without exposing young people to unnecessary risk."

The need for the FDA to review e-cigarettes on the market has been underscored by the recent surge in popularity of e-cigarette brand JUUL, which is used widely by high school and college students, a recent press release has explained.

Sold in various fruit and dessert flavours, the manufacturer claims that each JUUL cartridge contains as much nicotine as a pack of cigarettes.

The FDA in August 2016 implemented a new rule (known as the "deeming rule") extending its jurisdiction to e-cigarettes, cigars and other previously unregulated tobacco products. However, in August 2017, the FDA delayed a key provision of the rule that required manufacturers of products then on the market to provide critical information to the FDA about each product and undergo an FDA review of the product's impact on public health.

The FDA have now delayed the deadline for filing applications until August 2021 for cigars and other newly-regulated combustible products and until August 2022 for e-cigarettes. The FDA has also said that these products will remain on the market indefinitely during the review process and did not set a deadline for completing its review.

The health groups' lawsuit contends that the FDA's lengthy delay of product review deadlines exceeds the agency's authority under the Family Smoking Prevention and Tobacco Control Act (the 2009 law that established FDA oversight of tobacco products). It also contends that the FDA's decision violates the Administrative Procedure Act because the FDA did not give the public an opportunity to comment on the change and did not articulate an adequate factual basis for this radical change from the deadlines the FDA itself established in the deeming rule.

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Jun 24, 2021

Data de-identification - why it matters in healthcare

dataprivacy
patientdata
electronicmedicalrecords
datadeidentification
3 min
Riddhiman Das, co-founder and CEO of data privacy startup TripleBlind tells us why data de-identification is important in the healthcare sector

Large amounts of healthcare data is generated yet goes unused due to privacy concerns. To address this, data privacy firm TripleBlind has created Blind De-identification, a new approach that allows healthcare organisations to use patient data while eliminating the possibility of the user learning anything about the patient’s identity. 

We asked Riddhiman Das, co-founder and CEO to tell us more about data de-identification. 

Why is data de-identification important in healthcare? 
Blind De-identification allows every attribute of any given dataset to be used, even at an individual level, while being compliant to privacy laws, rules, and regulations by default.

Governments around the world are adopting global data privacy and residency laws like GDPR, which prohibit citizens’ personally identifiable information data from leaving the borders of the country. While great for data protection, data residency laws result in global silos of inaccessible data. TripleBlind allows computations to be done on enterprise-wise global data, while enforcing data residency regulations. 

In the US, HIPAA compliance has relied on what is called the Safe Harbor method, which requires removing 18 types of personal patient identifiers like names, email addresses, and medical record numbers. The Safe Harbor method can be too restrictive with the data or can leave too many indirect identifiers, which puts the patient data security at risk. Getting de-identification wrong could make an organisation liable for a costly mistake.

What does TripleBlind's solution do? 
With TripleBlind, data is legally de-identified in real time with practically 0% probability of re-identification. Our solution allows analytics on data containing personally identifiable information and protected health information  with zero possibility of re-identifying an individual from the dataset. This allows healthcare organisations to access more meaningful data, creating more accurate and less biased results.

For example, a healthcare drug researcher in a rural, predominantly white area, would only have patient data that would reflect their local population. With TripleBlind’s de-identification, they could more easily leverage third-party data from another healthcare facility in a more diverse region, creating a more complete data set that more accurately reflects the larger population. This has the possibility to create more accurate diagnoses and better drug results for more diverse populations.

How can healthcare organisations use this in practice? 
TripleBlind is blind to all data and algorithms. That means we never take possession of customer data. We only route traffic between entities, enforce permissions, and provide audit trails. The enterprise’s data remains under their control. TripleBlind does not host, copy or control their data, algorithms or other information assets, ever. 

We facilitate a connection to an encrypted version of their information assets. Our technology allows the algorithms and data to interact in an encrypted space that only exists for the duration of the operation. Organisations use their existing infrastructure, so it’s not hardware dependent.

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