Category: Family Health

By: Scott Hadland, MD, MPH, MS, FAAP

After years of talking with teens and their parents about substance use, here’s the single most important thing I’ve learned: Connection matters more than control.

I hear it from parents all the time: “I’m scared my teen might be using drugs, but I don’t know how to bring it up.” These fears are valid. Adolescence is a time of exploration and risk-taking, and today’s substances—from high-potency cannabis to counterfeit pills laced with fentanyl—are far more dangerous than in previous decades.

But here’s the good news: You have more influence than you think. Here, I’ll share what I often tell parents in my clinic: practical advice drawn from research and my experience having real-life conversations to help you keep your teen safe, supported and informed.

Start with connection, not control

When parents worry about substance use, the first instinct is often to tighten the reins: take away a teen’s phone, search their room and threaten punishment. But
research and experience show that what teens need most is connection, not control.

Start a conversation

Instead of jumping right to discipline, start a conversation. It’s best to have these talks early and often, long before you’re worried your teen has come home after using drugs or alcohol. Conversations are more productive when they happen outside the heat of the moment, when everyone is calm and open.

Ask open-ended questions like, “What have you heard about vaping at school?” or “How do your friends feel about drinking?” When teens feel judged, they shut down. But when they feel heard, they often open up.

Trust is protective. Scare tactics, on the other hand, can backfire. They can damage communication and make teens less likely to come to you when they’re in trouble.

Research shows that when teens feel mistrusted or
shamed, they’re more likely to hide their behavior rather than change it. Building a foundation of openness and honesty gives you more influence in the long run.

Know the substances teens are using

Substance use looks
different now than it did a generation ago. While alcohol is still the most commonly used substance among teens, high-potency cannabis use—especially in the form of vapes or edibles—is increasingly common. Nicotine vaping has also surged in recent years.

One of the biggest concerns today is the risk of
counterfeit pills. Some teens experiment with pills that they believe to be Xanax, Percocet or Adderall—when in fact, they may contain fentanyl or other drugs. Even one pill can be fatal because these contaminants are often highly potent and can cause an overdose quickly.

Staying informed about what teens are actually using can help you have more meaningful conversations. When teens sense that you’re up to date on what’s happening in their world—from the slang they use to the risks of vapes and edibles—they’re more likely to take you seriously. It also shows them that you care enough to understand, not just to judge.

When to involve your pediatrician or another professional

Sometimes, it’s hard to tell whether a teen is experimenting or truly struggling. If you notice changes in mood, sleep, appetite, school performance or friendships, bring it up with your pediatrician.

Pediatricians are trained to screen for substance use and mental health concerns. In addition, teens often feel more comfortable talking to a doctor than to a parent. In some cases, your pediatrician may recommend a counselor, therapist or substance use specialist.

For teens who are dealing with true addiction, it’s more
common than not that they’re also facing another mental health condition like anxiety, depression, ADHD or trauma. Treating both mental health and substance use problems together is essential—and help is available.

Focus on delay and safety, not perfection

One of the most important goals in adolescence is delaying substance use for as long as possible. The earlier a teen starts using, the more
likely they are to develop a substance use disorder (addiction) later in life. For example, teens who start using cannabis before age 18 are twice as likely to go on to have a problem with substance use disorder than if they start after they turn 18.

That said, the goal shouldn’t be perfection—it’s protection. Even if your teen has experimented, you can still make a difference. Be curious, and ask questions like, “How might you respond if someone at a party offers you a drink?”

Play to a teen’s strengths. For example, if your teen has an independent streak, tap into that. You might say, “You’ve never been someone who follows the crowd—how do you think that could help you make decisions if friends start using drugs or alcohol?“

Be clear about your values & set expectations.

There is a lot of positive messaging about alcohol and drugs on TV and in social media; sometimes you might be the only voice sharing that you think it’s important not to use substances.

Make a clear recommendation that you don’t want your teen to use. You might say, for example, “I care so much about your health and safety. I don’t want you using alcohol or other drugs, especially while your brain is still developing.” Teens may roll their eyes—but research shows they still
hear you, and it matters.

Don’t forget that parents can and should set limits and establish clear boundaries on a teen’s behavior. Read more about that here.

Safety first: rides & overdose prevention

One of the most important family rules to establish is about never driving under the influence—or riding with someone who is.

Let your teen know they can always call or text you (or another trusted adult) for a ride, no questions asked.

If you’re not available, ride share services like Uber or Lyft can be a good backup option—but only if your teen knows how to use them
safely. (Talk in advance about how to check the driver’s name, license plate and rating before getting in. Also remind them to sit in the back seat and share their trip status with you or another trusted adult.)

It’s also worth talking about
naloxone (Narcan), a medication that reverses opioid overdoses. Naloxone is safe, easy to use, and available in most pharmacies without a prescription. Every household—especially those with teens—should have it on hand.

Keep talking—it’s never just one talk

The most powerful prevention tool you have is your ongoing relationship with your teen. Don’t worry about giving one perfect lecture. What matters most is having lots of small conversations over time.

Talk during a car ride, while doing dishes, over Sunday family breakfast or at bedtime. Be curious. Be calm. Let them know you’re always there to talk—about anything. Even if your teen has already experimented, it’s never too late to help guide them.

Remember

Your relationship with your teen is the best protection against substance use. Stay curious. And reach out for support when you need it. We pediatricians are here to help.

More information

What it is

Carbon monoxide (CO) is an odorless, colorless gas that kills without warning. It claims the lives of hundreds of people every year and makes thousands more ill.

Many household items including gas- and oil-burning furnaces, portable generators, and charcoal grills produce this poison gas.

Symptoms

The most common symptoms of CO poisoning are headache, dizziness, weakness, upset stomach, vomiting, chest pain, and confusion. CO symptoms are often described as “flu-like.”

If you breathe in a lot of CO, it can make you pass out or kill you. People who are sleeping, drunk, or under the influence of other substances can die from CO poisoning before they have symptoms.

Risk factors

Everyone is at risk for CO poisoning. Infants, the elderly, and people with chronic heart disease, anemia, or breathing problems are more likely to get sick from CO.

Each year, more than 400 Americans die from unintentional CO poisoning not linked to fires, more than 100,000 visit an emergency department, and more than 14,000 are hospitalized.

Reducing risk

CO is found in fumes produced any time you burn fuel in cars or trucks, small engines, stoves, lanterns, grills, fireplaces, gas ranges, or furnaces. CO can build up indoors and poison people and animals who breathe it. However, you can reduce your risk of CO poisoning with a few small steps.

CO detectors

Install battery-operated or battery back-up CO detectors near every sleeping area in your home.

Check CO detector batteries when you change the time on your clocks each spring and fall to be sure they are functioning properly.

Consider buying a detector with a digital readout. This type of detector can tell you the highest level of CO concentration in your home, in addition to sounding an alarm.

Replace your CO detector following the manufacturer’s instructions or every 5 years. Set a reminder on your smartphone or other device calendar when you purchase and install the detector.

Oil and gas furnaces and other household appliances

Have your heating system, water heater, and any other gas, oil, or coal burning appliances serviced by a qualified technician every year.

Make sure your gas appliances are vented properly. Horizontal vent pipes for appliances, such as a water heater, should go up slightly as they go toward outdoors, as shown below. This prevents CO from leaking if the joints or pipes aren’t fitted tightly.

When you buy gas equipment, buy only equipment carrying the seal of a national testing agency, such as Underwriters’ Laboratories.

If you smell an odor from your gas refrigerator, have an expert service it. An odor from your gas refrigerator can mean it could be leaking CO.

Never heat your house with a gas oven.
Don’t cook or burn anything on a stove or fireplace that isn’t vented.

Chimneys, charcoal, and portable appliances

Have your chimney checked or cleaned every year. Chimneys can be blocked by debris, which can cause CO to build up inside your home or cabin.

Never burn charcoal indoors. Burning charcoal – red, gray, black, or white – gives off CO.

Never use a portable gas camp stove indoors.
Do not use portable flameless chemical heaters indoors.

Portable generators

Never use a generator inside your home or garage, even if doors and windows are open.

Only use generators outside, more than 20 feet away from any windows, doors, and vents.

When using a generator, use a battery-powered or battery backup CO detector in your home.

Automobile

Have a mechanic check the exhaust system of your car or truck every year. A small leak in the exhaust system can lead to a buildup of CO inside the car.

Never run your car or truck inside a garage that is attached to a house, even with the garage door open. Always open the door to a detached garage to let in fresh air when you run a car or truck inside.

If you drive a car or SUV with a tailgate, when you open the tailgate open the vents or windows to make sure air is moving through. If only the tailgate is open, CO from the exhaust will be pulled into the car or SUV.

The nonstop action and high-speed team play makes ice hockey a popular sport. As fun as it is, though, injuries can happen — some of them very serious.

To stay as safe as possible as a hockey player or hockey goalie, follow these tips.

Staying Safe & Preventing Injuries

What Hockey Safety Gear Do Players Need?

Before playing ice hockey, it’s important to get all the right equipment and make sure you know how to put it on and use it correctly. All players need:

Helmet

When it comes to preventing serious injuries, a helmet is the most important piece of gear. Helmets should be certified by the Hockey Equipment Certification Council (HECC ), include a full-face mask with a protective chin cup and chin strap, and should fit you properly. Keep the chin strap fastened and tightened so the helmet stays in place.

Skates

Be sure to get skates that fit you well. They need to be laced up tight, so the wrong size can really hurt your feet. Skates should have plenty of ankle support and a steel or hard plastic toe cup. Keep skates sharp so they work better and are less likely to get caught in ruts in the ice.

Shoulder Pads, Elbow Pads, Knee Pads, & Shin Pads

These are all specific to hockey. For example, gear used in soccer or lacrosse won’t give you the protection you need for playing hockey. Lower leg (knee and shin) pads should have a hard plastic exterior and reach the top of your skates.

Hockey Pants

Also called breezers, these should come down to the knee and offer padding in the front, rear, and sides of the upper legs and midsection.

Gloves

Another sport-specific item, hockey gloves should let your hands move freely while protecting you well past the wrist.

Athletic Supporter and Cup

These items are available as part of hockey undershorts or may be sold separately.

Neck Protector

Also called a neck guard, this gear protects the neck from injury (for example, from a skate blade or hockey stick). Choose one that fits you well and covers as much of the neck as possible.

Cut-Resistant Base Layers

Even with all the padding worn in hockey, any exposed skin areas are still vulnerable to accidental cuts from skate blades or forceful hits. For that reason, it’s now recommended that all players wear cut-resistant socks, wrist sleeves, and undergarments (base layer shirts and pants).

Mouth Guard

This protects the teeth, lips, cheeks, and tongue, and can help prevent jaw injuries.

What Safety Gear Do Goalies Need?

Hockey goalies need a whole different set of equipment to stay safe. If you are going to play that position, you need a helmet, skates, a neck protector, and an athletic cup specifically made for goalies. You should also wear:

Throat Protector

Worn in addition to a neck protector, this gear is worn to block a fast-moving puck or stick from hitting the neck. It is “flapper-style,” which means it attaches to your helmet and dangles just below the face mask, so it can move freely when the helmet moves.

Leg Pads

These need to be the right length and thick enough to protect against hard slapshots. Wear pants and socks underneath leg pads to cover any exposed skin.

Arm Pads & Chest Protector

Arm pads should reach all the way to the wrist. Chest protectors should wrap slightly around the sides to keep your entire front well protected.

Blocker Glove

This glove should let your fingers grip the stick easily but be very thick and cover most of the forearm.

Catcher Glove

Similar to a first baseman’s glove in baseball, a catcher glove should have thick padding over the wrist and palm and should come well up the forearm.

How Can I Stay Safe During Hockey Training & Games?

Before starting the season, you should get a sports physical. Your doctor can check for any health problems and talk about sports safety. Most schools won’t let athletes play unless they’ve had a sports physical during the past year. And being in good shape can help players avoid injuries.

It’s important to get comfortable on the ice before you learn hockey skills. It can help to take skating lessons and practice how to stop, turn, fall, and get up from a fall. It’s also helpful to know how to skate backward and stop and turn while skating backward.

To stay safe, you should:

• Always warm up and stretch before practice and matches.
• Follow the rules and use proper techniques. Learn how to collide with the boards safely and not with your head. This helps to prevent spinal injuries.
• Make sure your coach will be at all practices and games and will enforce all league safety rules.
• In general, never hit another player on the head, never check from behind, and never use the stick as a weapon.
• Stop playing if you feel pain or get hurt. Get checked by an athletic trainer, a coach, a doctor, or a nurse before going back on the rink.
• Know the symptoms of a concussion, like a headache, dizziness, or confusion. If you hit your head or don’t feel well, tell your trainer or coach right away. Follow return-to-play guidelines.
• Stay hydrated by drinking plenty of liquids before, during, and after games and practices.
• Know the team plan for emergencies.

What Else Should I Know?

Follow your coach’s safe, fair play rules at practices and games. Be respectful of the referees and don’t argue with their calls. Stay calm if an opposing player does something you disagree with. Don’t take it personally or start a fight — let the referees handle it.

It can help to play different sports throughout the year to prevent repetitive stress injuries (overuse injuries). These injuries happen when someone trains too much or makes the same motions over and over.

Safety in Other Sports

Safety matters whether you’re playing hockey or doing another athletic activity. To help prevent injuries in other sports, check out these articles:

SAIDs occur due to a defect in the immune system. This may be due to a genetic mutation, or there may not be a clear cause. Environmental factors may trigger the response in some people.

Your immune system protects you by detecting and fighting harmful substances in the body. These include bacteria, viruses, fungi, chemicals, toxins, and foreign particles (such as a splinter).

Your immune system involves:

• Innate immunity — this is the protection you were born with. Innate immunity involves barriers that keep harmful materials from entering your body. Examples include your skin, stomach acid, and mucus. This is the first line of defense against invaders.
• Adaptive immunity — this is the protection you gain as your body learns over time which substances are harmful. Your immune system builds a defense against that specific substance. Vaccines work by training your adaptive immunity to recognize harmful invaders, for example flu viruses, and attacking them.

SAIDs occur due to an abnormal reaction of innate immunity. Autoimmune diseases occur due to an abnormal reaction of
adaptive immunity.

When innate immunity is activated, it triggers your immune response. Certain chemicals in the body are released at the infection or injury site causing signs of inflammation, including redness, heat, pain, and swelling. Inflammation is part of the body’s self-healing process. As you recover from your illness or injury, inflammation goes away.

SAIDs occur when innate immunity is activated without a clear cause. This may cause inflammation to occur in excess or to last for long periods of time. Excess inflammation can damage healthy tissues in the skin, bones, eyes, liver, heart, or kidneys.

The defective MEFV gene responsible for the most common autoinflammatory disease, familial Mediterranean fever (FMF), was first identified in 1997. Since then, many SAIDs have been identified. Not all have a clear genetic cause.

There are more than 50 SAIDs, including:

• Familial Mediterranean fever (FMF)
• Tumor necrosis factor receptor-associated periodic syndrome (TRAPS)
• Cryopyrin-associated periodic syndromes (CAPS)
• Hyperimmunoglobulinemia D with periodic fever syndrome (HIDS)
• Aicardi-Goutières syndrome
• Blau syndrome
• Adult Still disease
• Hereditary angioedema
• Behçet disease

Each SAID affects people differently. Some occur for a few years and never return. Some last a life-time and need ongoing
management.

SAIDs can be passed down in families. So if your parent or siblings have an SAID, you are more at risk for also developing it.

Cardiac arrest can strike without warning. Do you suspect someone is experiencing cardiac arrest? The signs are:

• Sudden loss of responsiveness – The person doesn’t respond, even if you tap them hard on the shoulders or ask loudly if they’re OK. The person doesn’t move, speak, blink or otherwise react.
• No normal breathing – The person isn’t breathing or is only gasping for air.

What to do

If you think the person may be suffering cardiac arrest and you’re a trained lay rescuer:

• Ensure scene safety.
• Check for responsiveness.
• Shout for help. Tell someone nearby to call 911 or your emergency response number. Ask that person or another lay responder to bring you an AED (automated external defibrillator) if there’s one on hand. Tell them to hurry. Time is critical. If you’re alone with an adult who has signs of cardiac arrest, call 911 and get an AED (if one is available).
• Check for no breathing or only gasping. If the person isn’t breathing or is only gasping, begin CPR with compressions.
• Administer CPR. Push down at least two inches in the center of the chest at a rate of 100 to 120 pushes a minute. Allow the chest to return to its normal position after each push.
• Use an AED. As soon as it arrives, turn it on and follow the prompts.
• Continue CPR. Administer it until the person starts to breathe or move, or until someone with more advanced training, such as an EMS team member, takes over.

What treatment will I receive in the hospital?

Tests will be done to assess your condition. The test results can help the health care team decide on a treatment plan to reduce your risk of long-term health problems and death.

Your health care team will closely monitor your heart. They will also focus on preventing organ damage, especially to your brain.

You may receive one or more of the following treatments:

• Targeted temperature management (TTM) is a treatment to lower the body temperature to help protect the brain. Cooling blankets, cooling helmets, ice packs or other cooling methods may be used.
• Oxygen therapy helps you get enough oxygen so your organs continue to work as you are recovering.
• Extracorporeal membrane oxygenation (ECMO) treatment pumps your blood through an artificial lung. It adds oxygen and removes carbon dioxide from your blood before returning it to your body. The ECMO takes the stress off your lungs and heart to promote healing.

What other tests and treatments may I receive?

Your health care team will try to find out what caused your cardiac arrest. Some tests you may have include:

If you are diagnosed with coronary heart disease, treatment may include:

These treatments help restore blood flow through narrowed or blocked coronary arteries.

Genetic testing may be recommended for you and your blood relatives. This testing is done because some conditions that can increase the risk of cardiac arrest run in families.

It’s important to find out what caused your cardiac arrest. It’s also important for your family members to find out if they may be at risk of cardiac arrest due to an inherited condition or a gene that puts them at greater risk for one.

Am I at risk of another cardiac arrest?

If you’ve had one cardiac arrest, you may be at risk of another.

Your health care team may advise that you get an implantable cardioverter defibrillator (ICD). This may happen during your hospital stay or shortly after. Or you may be asked to wear an external cardiac defibrillator. Either can save your life by providing a low-energy shock to your heart to restore a normal heart rhythm if ventricular fibrillation or tachycardia occurs.

People with an ICD have some restrictions, though many can resume their normal activities.

How do I live with an ICD?

ICD batteries usually last four to seven years. Your health care professional should check them every three to six months.

Talk to your health care team about your activities. Ask them what you can and can’t do. Also ask which types of machines or equipment you should avoid. Those with magnets and strong electrical fields may interfere with your ICD’s operation.

You should also:

• Tell airport security guards that you have an ICD. Ask them not to use handheld metal detectors on you.
• Tell your other health care professionals, including your dentist, that you have an ICD.
• Tell the doctors and nurses that you have one anytime you go to the hospital.
• Always carry a card with the details about your ICD and emergency contact information so others know that you have one in case of a medical emergency.

What if I’m anxious about living with my ICD?

It’s common for people to feel anxious or depressed, especially in the first months or year after they get their ICD. You need to know that you are not alone or without support. If you have these feelings, talk with your health care team and get help.

45 CFR 164.501, 164.508, 164.512(i) (See also 45 CFR 164.514(e), 164.528, 164.532)  (Download a copy in PDF)

Background

The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes. Research is defined in the Privacy Rule as, “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” See 45 CFR 164.501.  A covered entity may always use or disclose for research purposes health information which has been de-identified (in accordance with 45 CFR 164.502(d), and 164.514(a)-(c) of the Rule) without regard to the provisions below.

The Privacy Rule also defines the means by which individuals will be informed of uses and disclosures of their medical information for research purposes, and their rights to access information about them held by covered entities. Where research is concerned, the Privacy Rule protects the privacy of individually identifiable health information, while at the same time ensuring that researchers continue to have access to medical information necessary to conduct vital research. Currently, most research involving human subjects operates under the Common Rule (45 CFR Part 46, Subpart A) and/or the Food and Drug Administration’s (FDA) human subject protection regulations (21 CFR Parts 50 and 56), which have some provisions that are similar to, but separate from, the Privacy Rule’s provisions for research. These human subject protection regulations, which apply to most Federally-funded and to some privately funded research, include protections to help ensure the privacy of subjects and the confidentiality of information. The Privacy Rule builds upon these existing Federal protections. More importantly, the Privacy Rule creates equal standards of privacy protection for research governed by the existing Federal human subject regulations and research that is not. 

How the Rule Works 

In the course of conducting research, researchers may obtain, create, use, and/or disclose individually identifiable health information. Under the Privacy Rule, covered entities are permitted to use and disclose protected health information for research with individual authorization, or without individual authorization under limited circumstances set forth in the Privacy Rule. Research Use/Disclosure Without Authorization. To use or disclose protected health information without authorization by the research participant, a covered entity must obtain one of the following: 

• Documented Institutional Review Board (IRB) or Privacy Board Approval. Documentation that an alteration or waiver of research participants’ authorization for use/disclosure of information about them for research purposes has been approved by an IRB or a Privacy Board. See 45 CFR 164.512(i)(1)(i). This provision of the Privacy Rule might be used, for example, to conduct records research, when researchers are unable to use de-identified information, and the research could not practicably be conducted if research participants’ authorization were required. A covered entity may use or disclose protected health information for research purposes pursuant to a waiver of authorization by an IRB or Privacy Board, provided it has obtained documentation of all of the following:
  • Identification of the IRB or Privacy Board and the date on which the alteration or waiver of authorization was approved; 
  • A statement that the IRB or Privacy Board has determined that the alteration or waiver of authorization, in whole or in part, satisfies the three criteria in the Rule; 
  • A brief description of the protected health information for which use or access has been determined to be necessary by the IRB or Privacy Board;
  • A statement that the alteration or waiver of authorization has been reviewed and approved under either normal or expedited review procedures; and 
  • The signature of the chair or other member, as designated by the chair, of the IRB or the Privacy Board, as applicable. 

The following three criteria must be satisfied for an IRB or Privacy Board to approve a waiver of authorization under the Privacy Rule: 

1. The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
   • an adequate plan to protect the identifiers from improper use and disclosure; 
   • an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and 
   • adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart; 
2. The research could not practicably be conducted without the waiver or alteration; and 
3. The research could not practicably be conducted without access to and use of the protected health information. 

• Preparatory to Research. Representations from the researcher, either in writing or orally, that the use or disclosure of the protected health information is solely to prepare a research protocol or for similar purposes preparatory to research, that the researcher will not remove any protected health information from the covered entity, and representation that protected health information for which access is sought is necessary for the research purpose. See 45 CFR 164.512(i)(1)(ii). This provision might be used, for example, to design a research study or to assess the feasibility of conducting a study.  The Privacy Rule does not prohibit a covered entity’s granting remote access to PHI to a researcher for activities that qualify as reviews preparatory to research, provided reasonable and appropriate safeguards are in place, as described in OCR’s guidance, Remote Access to PHI for Activities Preparatory to Research.
• Research on Protected Health Information of Decedents. Representations from the researcher, either in writing or orally, that the use or disclosure being sought is solely for research on the protected health information of decedents, that the protected health information being sought is necessary for the research, and, at the request of the covered entity, documentation of the death of the individuals about whom information is being sought. See 45 CFR 164.512(i)(1)(iii). 
• Limited Data Sets with a Data Use Agreement. A data use agreement entered into by both the covered entity and the researcher, pursuant to which the covered entity may disclose a limited data set to the researcher for research, public health, or health care operations. See 45 CFR 164.514(e). A limited data set excludes specified direct identifiers of the individual or of relatives, employers, or household members of the individual. The data use agreement must:
  • Establish the permitted uses and disclosures of the limited data set by the recipient, consistent with the purposes of the research, and which may not include any use or disclosure that would violate the Rule if done by the covered entity; 
  • Limit who can use or receive the data; and 
  • Require the recipient to agree to the following:
    • Not to use or disclose the information other than as permitted by the data use agreement or as otherwise required by law; 
    • Use appropriate safeguards to prevent the use or disclosure of the information other than as provided for in the data use agreement; 
    • Report to the covered entity any use or disclosure of the information not provided for by the data use agreement of which the recipient becomes aware; 
    • Ensure that any agents, including a subcontractor, to whom the recipient provides the limited data set agrees to the same restrictions and conditions that apply to the recipient with respect to the limited data set; and
    • Not to identify the information or contact the individual. 
• Research Use/Disclosure With Individual Authorization. The Privacy Rule also permits covered entities to use or disclose protected health information for research purposes when a research participant authorizes the use or disclosure of information about him or herself. Today, for example, a research participant’s authorization will typically be sought for most clinical trials and some records research. In this case, documentation of IRB or Privacy Board approval of a waiver of authorization is not required for the use or disclosure of protected health information. To use or disclose protected health information with authorization by the research participant, the covered entity must obtain an authorization that satisfies the requirements of 45 CFR 164.508. The Privacy Rule has a general set of authorization requirements that apply to all uses and disclosures, including those for research purposes. However, several special provisions apply to research authorizations:
  • Unlike other authorizations, an authorization for a research purpose may state that the authorization does not expire, that there is no expiration date or event, or that the authorization continues until the “end of the research study”.
  • An authorization for the use or disclosure of protected health information for a research study may be combined with a consent to participate in the research, or with any other legal permission related to the research study.
  • An authorization for the use or disclosure of protected health information for a research study may be combined with an authorization for a different research activity, provided that, if research-related treatment is conditioned on the provision of one of the authorizations, such as in the context of a clinical trial, then the compound authorization must clearly differentiate between the conditioned and unconditioned components and provide the individual with an opportunity to opt in to the unconditioned research activity.
  • An authorization may be obtained from an individual for uses and disclosures of protected health information for future research purposes, so long as the authorization adequately describes the future research such that it would be reasonable for the individual to expect that his or her protected health information could be used or disclosed for the future research purposes.
  • New Guidance on HIPAA and individual authorization of uses and disclosures of protected health information for research.  This guidance explains certain requirements for an authorization to use or disclose PHI for future research.  The guidance also clarifies aspects of the individual’s right to revoke an authorization for research uses and disclosures of PHI.
• Accounting for Research Disclosures. In general, the Privacy Rule gives individuals the right to receive an accounting of certain disclosures of protected health information made by a covered entity. See 45 CFR 164.528. This accounting must include disclosures of protected health information that occurred during the six years prior to the individual’s request for an accounting, or since the applicable compliance date (whichever is sooner), and must include specified information regarding each disclosure. A more general accounting is permitted for subsequent multiple disclosures to the same person or entity for a single purpose. See 45 CFR 164.528(b)(3). Among the types of disclosures that are exempt from this accounting requirement are:
  • Research disclosures made pursuant to an individual’s authorization; 
  • Disclosures of the limited data set to researchers with a data use agreement under 45 CFR 164.514(e). 

In addition, for disclosures of protected health information for research purposes without the individual’s authorization pursuant to 45 CFR164.512(i), and that involve at least 50 records, the Privacy Rule allows for a simplified accounting of such disclosures by covered entities. Under this simplified accounting provision, covered entities may provide individuals with a list of all protocols for which the patient’s protected health information may have been disclosed under 45 CFR 164.512(i), as well as the researcher’s name and contact information. Other requirements related to this simplified accounting provision are found in 45 CFR 164.528(b)(4). 

Transition Provisions. Under the Privacy Rule, a covered entity may use and disclose protected health information that was created or received for research, either before or after the applicable compliance date, if the covered entity obtained any one of the following prior to the compliance date

• An authorization or other express legal permission from an individual to use or disclose protected health information for the research; 
• The informed consent of the individual to participate in the research; 
• A waiver of authorization approved by either an IRB or a privacy board (in accordance with 45 CFR  164.512(i)(1)(i)); or
• A waiver of informed consent by an IRB in accordance with the Common Rule or an exception under FDA’s human subject protection regulations at 21 CFR 50.24. However, if a waiver of informed consent was obtained prior to the compliance date, but informed consent is subsequently sought after the compliance date, the covered entity must obtain the individual’s authorization as required at 45 CFR 164.508. For example, if there was a temporary waiver of informed consent for emergency research under the FDA’s human subject protection regulations, and informed consent was later sought after the compliance date, individual authorization would be required before the covered entity could use or disclose protected health information for the research after the waiver of informed consent was no longer valid. The Privacy Rule allows covered entities to rely on such express legal permission, informed consent, or waiver of authorization of informed consent, which they create or receive before the applicable compliance date, to use and disclose protected health information for specific research studies, as well as for future unspecified research that may be included in such permission.

OCR HIPAA Privacy
December 3, 2002 Revised December 18, 2017

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Other HIPAA and Research Resources

Causes of childhood MEN1 syndrome 

Genetic counseling for children who may have MEN1 syndrome

Symptoms of tumors caused by childhood MEN1 syndrome

Tests to diagnose tumors caused by MEN1 syndrome

Getting a second opinion

Cancer surveillance for children with MEN1 syndrome

Who treats children with tumors caused by MEN1 syndrome?

Treatment of children with tumors caused by MEN1 syndrome

Clinical trials

Prognosis for children with tumors caused by MEN1 syndrome 

Follow-up care

Coping with your child’s cancer