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Why Theranos CEO Elizabeth Holmes Should Be Banned

Why Theranos CEO Elizabeth Holmes Should Be Banned | Pharma Law | Scoop.it
When startups fail, founders don't get an 'A' for effort. That's not how it works in the real world -- certainly not when lives are at stake.
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Brookings calls out OCR on HIPAA audits, offers security tips for healthcare organizations

Brookings calls out OCR on HIPAA audits, offers security tips for healthcare organizations | Pharma Law | Scoop.it
With the healthcare industry suddenly accounting for nearly 25 percent of all data breaches, a new study from The Brookings Institution suggests some new cybersecurity strategies are needed.
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Justice Department recovers nearly $6 billion from False Claims Act cases in 2014 - Lexology (registration)

Justice Department recovers nearly $6 billion from False Claims Act cases in 2014 - Lexology (registration) | Pharma Law | Scoop.it
The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims…
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SD to sharpen focus on fraud cases in health care - Sioux Falls Argus Leader

SD to sharpen focus on fraud cases in health care - Sioux Falls Argus Leader | Pharma Law | Scoop.it
SD to sharpen focus on fraud cases in health care
Sioux Falls Argus Leader
Johnson said his office has put together a new team of lawyers from both the criminal and civil divisions that will devote “significant time” to investigating fraud.
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Two Months to Amend HIPAA Business Associate Agreements for Omnibus Compliance, But Beware the Bare Bones BAA | HIPAA, HITECH & HIT

Two Months to Amend HIPAA Business Associate Agreements for Omnibus Compliance, But Beware the Bare Bones BAA | HIPAA, HITECH & HIT | Pharma Law | Scoop.it

Two Months to Amend HIPAA Business Associate Agreements for Omnibus Compliance, But Beware the Bare Bones BAABy Elizabeth Litten on July 22, 2014 Posted in HIPAA Enforcement, Omnibus Rule

Does your business associate agreement (BAA) reflect your business deal, or is it a bare bones HIPAA compliance document?

Now is the time to check. The HIPAA “Omnibus Rule” published in January of 2013 gave covered entities, business associates, and subcontractors until September 22, 2014 to make their business associate agreements (BAAs) compliant, so use the next few weeks to make sure your BAA complies with the law and reflects your business deal.

Copyright: clairev / 123RF Stock Photo

HHS published a bare bones sample BAA when the Omnibus Rule came out, and a number of posts to this blog provide tips that can be used in reviewing and updating your BAA.

But don’t forget that a good BAA supports and is supported by the underlying services contract between the parties, and should be the meat on the bones of the BAA and the brain behind it. A perfectly HIPAA-compliant BAA will crumble into dust if it’s not written to reflect and support the services contract and underlying business deal. Here are two key questions to ask to make sure the business deal and BAA are working in synch:

Question 1: Who are the parties to the BAA?

What are the roles of the parties under HIPAA? Check definitions and what is being performed by one party “on behalf of” the other.
If the business associate is really a subcontractor (because the covered entity is really a business associate or subcontractor itself), does the BAA (or subcontractor agreement (SA)) recognize and describe the privacy and security obligations imposed by the BAA above it? Has such BAA or subcontractor actually reviewed the BAA or SA above it?If both parties are covered entities, does the BAA clearly describe when the business associate is acting as such, and not as its own covered entity?Will the covered entity ever act as a business associate in relation to the other party?

Question 2: What is the business reason for or purpose of the use and/or disclosure of protected health information (PHI)?

What is the reason PHI is being created, received, maintained or transmitted on behalf of the covered entity, business associate or subcontractor?Do the parties have reciprocal obligations to abide by privacy and security standards, such as minimum necessary standards?Will the business associate (or subcontractor) have any claim to own, de-identify, aggregate, modify or keep data derived from the PHI that is the subject of the BAA (for example, will the business associate’s activities with respect to the PHI under the BAA produce other data or data sets not subject to or contemplated by the services contract)?

The bottom line? Before the summer fades (and certainly before September 22nd), make sure your BAA meets the Omnibus Rule requirements, but also make sure it reflects and supports your business deal. The bare bones BAA may not be what you want or need.

 

 


Via Technical Dr. Inc.
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HIPAA Enforcement On The Rise, Criminal Prosecutions Become More Prevalent - Food, Drugs, Healthcare, Life Sciences - United States

HIPAA Enforcement On The Rise, Criminal Prosecutions Become More Prevalent - Food, Drugs, Healthcare, Life Sciences - United States | Pharma Law | Scoop.it

As the Federal Government has moved to more aggressive enforcement of the Health Insurance Portability and Accountability Act  ("HIPAA")  privacy provisions, providers and payers are experiencing significant challenges responding to and addressing privacy violations. A subset of aggressive enforcement efforts is the effort in specific circumstances to bring criminal prosecutions.

Earlier this month, The U.S. Attorney for the Eastern District of Texas announced a criminal indictment of a former employee of an East Texas Hospital for criminal violations of the HIPAA. The former employee was indicted on  charges of Wrongful Disclosure of Individually Identifiable Health Information.  According to the indictment, from December 1, 2012, through January 14, 2013, the employee obtained protected health information with the intent to use the information for personal gain.

42 U.S.C. §1320d-6(b) provides for criminal penalties as a result of certain types of violations of the HIPAA privacy protections. The statute provides in pertinent part that "...[a] person who knowingly...(1) uses or causes to be used a unique health identifier; (2) obtains individually identifiable health information relating to an individual; or (3) discloses individually identifiable health information to another person, shall be.." subject to certain specified penalties. The penalties include a fine of not more than $50,000 and imprisonment of not more than 1 year, or both. The penalties then increase if: (1)  the violation was committed under false pretenses, the  penalties increase to a fine of not more than $100,000, imprisonment of not more than 5 years, or both; or (2) if the violation is committed with intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm, the penalties increase to a fine of not more than $250,000, imprisoned of not more than 10 years, or both.

The defendant in this Texas case was indicted on the most serious offense involving the use of  individually identifiable health information for commercial advantage, personal gain, or malicious harm and faces up to ten years in prison. 

Providers and payers are likely to see more criminal prosecutions of individuals. The investigations, however, may expose, to the extent they exist, HIPAA non-compliance or related violations on the provider or payers part. The simple message is to redouble efforts to ensure HIPAA compliance.

 

 


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Anti-Kickback Laboratory Enforcement Actions ... - Med Law Blog

Anti-Kickback Laboratory Enforcement Actions ... - Med Law Blog | Pharma Law | Scoop.it
There has been significantly enhanced scrutiny of financial relationships between referring physicians by both the Office of Inspector General (OIG) and Pe.
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CMS Proposed Changes Take Sunshine Act From "Decent Idea to Regulatory ... - Medical Device and Diagnostics Industry (blog)

CMS Proposed Changes Take Sunshine Act From "Decent Idea to Regulatory ... - Medical Device and Diagnostics Industry (blog) | Pharma Law | Scoop.it
CMS Proposed Changes Take Sunshine Act From "Decent Idea to Regulatory ...
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We Don't Need No Intervention: Qui Tam Relator in Omnicare Wins Big Without ... - JD Supra (press release)

We Don't Need No Intervention: Qui Tam Relator in Omnicare Wins Big Without ...
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Supreme Court Set to Decide Important False Claims Act Issue

Supreme Court Set to Decide Important False Claims Act Issue | Pharma Law | Scoop.it
The U.S. Supreme Court has agreed to review a case involving the Wartime Suspension of Limitations Act— an issue that has been central to recent False Claims Act litigation.
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Infographic: There's No Such Thing as a HIPAA-compliant App | mHealthNews

Infographic: There's No Such Thing as a HIPAA-compliant App | mHealthNews | Pharma Law | Scoop.it
Noncompliance with HIPAA regulations can have serious repercussions for healthcare organizations.
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Medicare's Sunshine Act changes could hit device makers in the ...

Medicare's Sunshine Act changes could hit device makers in the ... | Pharma Law | Scoop.it
The Centers for Medicare & Medicaid Services proposes 4 changes to physician payment transparency rules that could mean major new costs for medical device makers.
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Why Hospitals Are the Perfect Targets for Ransomware

Why Hospitals Are the Perfect Targets for Ransomware | Pharma Law | Scoop.it
As a third hospital gets hit with what is likely ransomware, experts explain why they are such vulnerable marks for ransomware and what they need to do to fight back.
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Fitbit guns for the workplace as it achieves HIPAA compliance - Ars Technica

Fitbit guns for the workplace as it achieves HIPAA compliance - Ars Technica | Pharma Law | Scoop.it
Target employees get activity trackers as Fitbit expands its corporate program.
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The High Price of Healthcare Fraud Likely to Keep Getting Higher - Metropolitan Corporate Counsel

The High Price of Healthcare Fraud Likely to Keep Getting Higher - Metropolitan Corporate Counsel | Pharma Law | Scoop.it
The High Price of Healthcare Fraud Likely to Keep Getting Higher Metropolitan Corporate Counsel In applying fair market value to healthcare fraud and abuse-related issues, including the Stark law and federal Anti-Kickback Statute, the term...
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10 Tips for Responding to a False Claims Act Investigation | JD Supra

An increase in government investigations and enforcement actions under the False Claims Act (FCA) and other federal laws can subject healthcare organizations, financial services firms,...
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Social Media and Privacy Concerns in Dental Care

Social Media and Privacy Concerns in Dental Care | Pharma Law | Scoop.it

Patient health data is sensitive information and protected by various laws such as the HITECH act and HIPAA rule. Healthcare entities, doctors, nurses and other employees are bound to protect patient data and ensure that it remains confidential. Patients themselves are worried that sharing health information (such as a diagnosis of mental illness) can lead to loss of job opportunities or healthcare benefits.
  
One of the reasons why the use of social media is discouraged within the healthcare system is because it is difficult to control the spread of information through social networking sites. Websites such as Facebook or Twitter are not covered by the HIPAA rule and information posted on such networks may be accessible by an authorized users, unintentionally or deliberately. This is also why sharing of health information through EHRs has received a lot of attention in the meaningful use program.
  
In spite of the anxieties regarding privacy of health data, two recent surveys have found that 94% of patients are willing to share medical data if it helps doctors to provide better care or to provide support to patients with similar conditions (Surveys conducted by CRNRC and PLM, March and October 2012). 84% of patients would even be willing to share their medical data (anonymized) with pharmaceutical companies to improve drug research.
  
These numbers seem to contradict patients’ claims that they are worried about privacy issues. However researchers speculate that this may be because many patients realize that the benefits of sharing information outweigh the detrimental effects. It appears that patients are concerned mainly with how their data is being used and who can access it, not that it should be kept under lock and key.
  
For example, a patient diagnosed with cancer may be willing to share his medical data with doctors or drug companies. At the same time, he may not want his colleagues or boss to know about his illness or for his children to find out about it from Facebook. Some people diagnosed with terminal or life altering illnesses have even opted to share their struggles with the disease on blogs or online journals.
  
At present there are no laws governing the use of medical data posted on social media by patients themselves. Although marketers are required to obtain consent before collecting information, many of them pose as users and are not prosecuted for violating the website’s terms of service. However, the role of the Internet in people’s lives is growing rapidly and more consumers are becoming comfortable with sharing information online. Pretty soon, nations may have to consider implementing laws which protect medical data on social media as well.

 


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MedMan's Attorney Explains Waiving Copays and Deductibles ...

MedMan's Attorney Explains Waiving Copays and Deductibles ... | Pharma Law | Scoop.it
Anti-Kickback Statute. The federal Anti-Kickback Statute (“AKS”) prohibits knowingly and willfully offering, paying, soliciting or receiving remuneration to any person to induce such person to order or receive any items or ...
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Physicians, Medical Groups Beware Recent OIG Special Fraud Alert ...

Physicians, Medical Groups Beware Recent OIG Special Fraud Alert ... | Pharma Law | Scoop.it
The anti-kickback statute may be violated when a payment for blood specimen collection, processing, and packaging is made, but it depends on the intent of the parties. Specifically, if any portion of the reason the payment is ...
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If Your Sunshine Act Submissions Aren't Accurate, You Could Be in Big Trouble - Bloomberg BNA

If Your Sunshine Act Submissions Aren't Accurate, You Could Be in Big Trouble - Bloomberg BNA | Pharma Law | Scoop.it
If Your Sunshine Act Submissions Aren't Accurate, You Could Be in Big Trouble Bloomberg BNA We're less than two months out from the public release of Sunshine Act data, and while the initial data submissions have already been made, it's an ongoing...
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Astellas Pharma settles False Claims Act allegations over Mycamine ...

A lawsuit was filed against Astellas in U.S. District Court for the Eastern District of Pennsylvania under the whistleblower provisions of the False Claims Act and similar state false claims statutes.
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DOJ Intervenes In False Claims Act Case and Alleges Violation for ...

DOJ Intervenes In False Claims Act Case and Alleges Violation for ... | Pharma Law | Scoop.it
It joined in claims under the federal False Claims Act against New York City's Continuum Health Partners and its constituent hospitals based on the defendants' failure to return Medicaid overpayments within sixty (60) days of ...
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$150,000 Settlement in Hospital Breach

$150,000 Settlement in Hospital Breach | Pharma Law | Scoop.it
The Massachusetts attorney general has reached a $150,000 HIPAA settlement with a Rhode Island hospital in the wake of a 2012 data breach that affected 14,000 (RT @healthinfosec: $150,000 Settlement in Hospital #Breach: State #HIPAA Case Stems from...
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Criminals Have Their Eyes on Your Patients’ Records | EMR and HIPAA

Criminals Have Their Eyes on Your Patients’ Records | EMR and HIPAA | Pharma Law | Scoop.it
The following is a guest blog post by Art Gross, Founder of HIPAA Secure Now!
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