Consumer Protection Science, Computers & Technology Health

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HIPAA Compliance: Navigating a Health Care Minefield

In the two decades since its original passage, complying with the federal Health Insurance Portability and Accountability Act (HIPAA) hasn’t gotten any easier. Enacted with the primary goal of protecting the confidentiality,...more

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

OCR Warns of HIPAA Risks in Third-Party Apps

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently issued a warning regarding vulnerabilities in third-party applications used by entities covered by HIPAA. The OCR warning applies...more

Practice Fusion and FTC Settle Complaint Over Deceptive Statements About the Privacy of Consumer-Generated Online Content

Last week, the Federal Trade Commission (FTC) announced (press release) that Practice Fusion, the largest cloud-based electronic health company in the United States, has agreed to settle FTC charges over deceptive practices...more

Cybersecurity News & Notes – June 2016 #3

In Case You Missed It: Illinois strengthened its data privacy and security law, with the amendments going into effect in January 2017. The amendments include expanding the definition of “personal information” to include a...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

PowerPoint Slides: Could My Company's Website Violate the Americans with Disabilities Act?

Under the Americans with Disabilities Act (ADA), places of public accommodation must ensure equal access to the goods and services they offer to disabled individuals. Is a company website subject to the ADA? The answer to...more

Wrap-Up of Federal and State Chemical Regulatory Developments, June 2016

TSCA/FIFRA/IRIS/NTP/TRI - TSCA Reform Bill Is Sent To President Obama For Signature: It has been reported that on June 14, 2016, House Speaker Paul Ryan (R-WI) and Senate President Pro Tempore Orrin Hatch (R-UT) signed...more

Illinois Joins the Fray: Strengthens its Laws Around Data Breach Notification and Data Security

Sophisticated phishing scams and muscular hacking efforts continue to compromise personal and sensitive information held by insurers, hospital systems, and businesses large and small. In response, many states have...more

Webinar: Could My Company's Website Violate the Americans with Disabilities Act? [Video]

Under the Americans with Disabilities Act (ADA), places of public accommodation must ensure equal access to the goods and services they offer to disabled individuals. Is a company website subject to the ADA? The answer to...more

OTC Drug Regulatory Paradigm Open to Stakeholder Feedback Until July 10

Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the...more

European General Data Protection Regulation to Apply from May 2018

In Depth - On 4 May 2016, the General Data Protection Regulation (GDPR), was published in the Official Journal of the European Union (L 119/1). It will apply from 25 May 2018, at which point it replaces the current legal...more

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

Kansas Heart Hospital pays ransom but attackers renege on their word

In a rare and twisted result, Kansas Heart Hospital was hit with a ransomware attack on May 18th, and made the decision to pay a “small amount” to the attackers in order to get its data back. Kansas Heart stated that no...more

FDA Regulatory and Compliance Monthly Recap – May 2016

FDA draft guidance provides recommendations on use of electronic health record data in clinical trials - The draft guidance provides recommendations on deciding whether and how to use EHRs as a source of data in clinical...more

Is Sponsor-Submitted Clinical Data Safe?

The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety,...more

Superior Court of Pennsylvania Denies Data Breach Class Certification

In an encouraging development for data breach defendants, the Superior Court of Pennsylvania recently affirmed a trial court decision rejecting class certification in a suit filed against two Medicare programs for losing a...more

FDA Outlines Future Medical Device Coordinating Center

The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to...more

Changes in the regulatory control of the pharmaceutical market - Q1 2016 Review

Until January 1, 2017, for confirming the state registration of a foreign medicinal product, it is permitted to present a certificate of GMP ?ompliance (obtained in the country of origin) to the applicable GMP standards in...more

Developing and Implementing an Effective Telemedicine Informed Consent Form

The search by consumers, payers and providers for more efficient, effective and convenient care delivery models has led to an explosion of technological innovation in the health care sector. This explosion has supported the...more

Facebook, Healthcare Provider Websites and HIPAA

In a class action Complaint filed in the Northern District of California on March 15, 2016, Kiesel Law LLP, on behalf of primary plaintiff Winston Smith and a potential class of others, alleges that Facebook received...more

FDA Regulatory and Compliance Monthly Recap — April 2016

FDA finalizes guidance on drug design in attempt to reduce medication errors - The finalized guidance revises draft guidance published in 2012 to address public comments calling for clarifications and formatting changes,...more

Wyoming Medical Center victim of phishing scheme affecting 3,184 patients

Phishing incidents in February that may have compromised the data of 3,184 patients, including their names, dates of birth, medical record and account numbers, dates of service and medical information is causing Wyoming...more

Spring Showers Bring HIPAA Breaches

OCR has announced several recent settlement agreements to resolve violations of the Health Insurance Portability and Accountability Act (“HIPAA”). These settlement amounts range from $25,000 to $3.9 million dollars and...more

OCR Releases Updated HIPAA Audit Protocol and Business Associate Listing Template

The Office of Civil Rights (OCR) recently updated the audit protocol that it will be using to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA)...more

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